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Feasibility and Safety of Acupuncture in the Prevention of Late Irinotecan-related Diarrhea in Pediatric Patients (AIP2021)

Primary Purpose

Pediatric Cancer, Solid Tumor

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pediatric Cancer focused on measuring cancer, children, diarrhea, acupuncture, irinotecan

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients from 0 to 18 years old with solid tumors who start treatment in our center with irinotecan at 50 mg/m2/intravenous dose in day hospital.
  • Blood tests prior to the start of the appropriate chemotherapy cycle to receive acupuncture with continuous stimulation needle insertion: neutrophils greater or equal to 1000 cells/mm3 and platelets greater than or equal to 50,000 cells/mm3.
  • Signature of informed consent by parents in the case of children under 12 years of age and assent of the minor.
  • Signature of informed consent in the case of those over 12 years of age

Exclusion Criteria:

  • Participate in a clinical trial that is developed in the Pediatric Oncology Area of the Hospital Sant Joan de Deu where acupuncture intervention is not permitted.
  • Have received acupuncture treatment in the last ten days.
  • Receive concomitant abdominal radiotherapy.
  • Have diarrhea on day 1 of the cycle

Sites / Locations

  • Hospital Sant Joan de DeuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Pre-Post feasibility treatment On the first cycle of irinotecan, the patient does not receive any intervention, we only collect data. This is the control cycle. There will be a single study group that will be used at the same time as your own control. On the second cycle of irinotecan, the patient receives acupuncture. There will be a single study group that will be used at the same time as your own control.

Outcomes

Primary Outcome Measures

Pain intensity during the procedure
Evaluation of pain intensity during the insertion procedure of the indwelling needles. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Pain intensity during the procedure
Evaluation of pain intensity during the insertion procedure of the indwelling needles. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.

Secondary Outcome Measures

Pain intensity during the intervention
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Pain intensity during the intervention
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Pain intensity during the intervention
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Pain intensity during the intervention
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Pain intensity during the intervention
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Pain intensity during the intervention
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Pain intensity during the intervention
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Pain intensity during the intervention
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Pain intensity during the intervention
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Side effects
Registry of other local adverse effects of acupuncture. will be delivered families recorded some items on day 9 of the second cycle (intervention cycle): local infection, hematoma, and skin damage.
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Degree of severity of diarrhea
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antidiarrheal drugs
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Prophylactic regimen of cefixime
Prophylactic regimen of cefixime before starting the cycle of irinotecan and the use of regimen prolonged 10 days. (Yes/No)
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Abdominal pain treatment-related
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Satisfaction degree
Degree of satisfaction with acupuncture through a qualitative survey. Three items Yes/No and free comments
Determination of the UGT1A1 polymorphism
Determination of the UGT1A1 polymorphism by blood sample in the analysis of routine performed on day 1 of the first cycle of irinotecan (control cycle).
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Nausea
Record whether or not the patient has nausea (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Vomiting
Record whether or not the patient has vomiting (YES/NO)
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Dose of antiemetic drugs (ondasentron)
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.

Full Information

First Posted
July 6, 2022
Last Updated
August 18, 2022
Sponsor
Fundació Sant Joan de Déu
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1. Study Identification

Unique Protocol Identification Number
NCT05507736
Brief Title
Feasibility and Safety of Acupuncture in the Prevention of Late Irinotecan-related Diarrhea in Pediatric Patients
Acronym
AIP2021
Official Title
Feasibility and Safety of the Use of Acupuncture in the Prevention of Late-onset Diarrhea Associated With Irinotecan in Pediatric Patients With Solid Tumors: Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the feasibility of an acupuncture protocol in the prevention of late diarrhea due to irinotecan in pediatric patients with solid tumors, a pre-post pilot study will be conducted. Pre-post pilot study non-randomized, open label, single arm study. There will be a single study group that will be used at the same time as your own control. The intervention will take place for approximately one year.
Detailed Description
Pre-post pilot study non-randomized, open label, single arm study. The objective of this pilot study is to demonstrate that cancer acupuncture pediatric treatment is a safe and feasible treatment in the prevention of late-onset diarrhea related to with irinotecan. This pilot study will include patients between 0 and 18 years of age with a solid tumor (nephroblastoma, neuroblastoma, central nervous system tumors and rhabdomyosarcoma) receiving their first cycle of irinotecan, in our center, at 50 mg/m2/intravenous dose daily for five days (cumulative dose weekly = 250 mg/m2) and who do not receive concomitant abdominal radiotherapy. Acupuncture will be applied as a complementary treatment along with the usual regimen of prophylaxis and treatment of late diarrhea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer, Solid Tumor
Keywords
cancer, children, diarrhea, acupuncture, irinotecan

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post feasibility
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Pre-Post feasibility treatment On the first cycle of irinotecan, the patient does not receive any intervention, we only collect data. This is the control cycle. There will be a single study group that will be used at the same time as your own control. On the second cycle of irinotecan, the patient receives acupuncture. There will be a single study group that will be used at the same time as your own control.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
Indwelling, sterile and disposable needles (SEIRIN NEW PYONEX®)
Intervention Description
13 Indwelling, sterile and disposable needles (SEIRIN NEW PYONEX® from 0.9 mm in length and 0.22 mm in diameter) on day 1 and 5 of the second cycle of irinotecan leaving them inserted for 4 days.
Primary Outcome Measure Information:
Title
Pain intensity during the procedure
Description
Evaluation of pain intensity during the insertion procedure of the indwelling needles. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 1
Title
Pain intensity during the procedure
Description
Evaluation of pain intensity during the insertion procedure of the indwelling needles. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Pain intensity during the intervention
Description
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 1
Title
Pain intensity during the intervention
Description
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 2
Title
Pain intensity during the intervention
Description
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 3
Title
Pain intensity during the intervention
Description
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 4
Title
Pain intensity during the intervention
Description
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 5
Title
Pain intensity during the intervention
Description
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 6
Title
Pain intensity during the intervention
Description
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 7
Title
Pain intensity during the intervention
Description
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 8
Title
Pain intensity during the intervention
Description
Evaluation of the intensity of the pain during the days that the indwelling needles remain inserted. It will be evaluated with the same tools as the variable major. The scales will be used: crying scale (0-8) (<3 years), Wong-Baker scale of faces for cooperative children (0-10) (>3 years) and numerical scale (0-10) for collaborating children (>6 years). Higher scores mean a worse result.
Time Frame
Day 9
Title
Side effects
Description
Registry of other local adverse effects of acupuncture. will be delivered families recorded some items on day 9 of the second cycle (intervention cycle): local infection, hematoma, and skin damage.
Time Frame
Day 9
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 1
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 2
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 3
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 4
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 5
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 6
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 7
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 8
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 9
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 10
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 11
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 12
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 13
Title
Degree of severity of diarrhea
Description
Degree of severity of diarrhea according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (1-5). It will be evaluated after collection of data from the registration tables that families fill out. Higher scores mean a worse result. Grade 1: Increase of <4 stools per day over baseline. Grade 2: Increase of 4 - 6 stools per day over baseline Grade 3: Increase of >=7 stools per day over baseline; hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Time Frame
Day 14
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 1
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 2
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 3
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 4
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 5
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 6
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 7
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 8
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 9
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 10
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 11
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 12
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 13
Title
Dose of antidiarrheal drugs
Description
Dose of antidiarrheals: the number of daily doses of loperamide (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 14
Title
Prophylactic regimen of cefixime
Description
Prophylactic regimen of cefixime before starting the cycle of irinotecan and the use of regimen prolonged 10 days. (Yes/No)
Time Frame
Day 1
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 1
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 2
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 3
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 4
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 5
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 6
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 7
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 8
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 9
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 10
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 11
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 12
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 13
Title
Abdominal pain treatment-related
Description
Degree of abdominal pain assessed with a visual analog scale of 0-10. Higher scores mean a worse result.
Time Frame
Day 14
Title
Satisfaction degree
Description
Degree of satisfaction with acupuncture through a qualitative survey. Three items Yes/No and free comments
Time Frame
Day 15
Title
Determination of the UGT1A1 polymorphism
Description
Determination of the UGT1A1 polymorphism by blood sample in the analysis of routine performed on day 1 of the first cycle of irinotecan (control cycle).
Time Frame
Day 1
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 1
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 2
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 3
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 4
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 5
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 6
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 7
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 8
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 9
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 10
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 11
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 12
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 13
Title
Nausea
Description
Record whether or not the patient has nausea (YES/NO)
Time Frame
Day 14
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 1
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 2
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 3
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 4
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 5
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 6
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 7
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 8
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 9
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 10
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 11
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 12
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 13
Title
Vomiting
Description
Record whether or not the patient has vomiting (YES/NO)
Time Frame
Day 14
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 1
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 2
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 3
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 4
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 5
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 6
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 7
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 8
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 9
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 10
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 11
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 12
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 13
Title
Dose of antiemetic drugs (ondasentron)
Description
Dose of antidiarrheals: the number of daily doses of ondasentron (0-4 doses/day) will be recorded. Higher scores mean a worse result.
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients from 0 to 18 years old with solid tumors who start treatment in our center with irinotecan at 50 mg/m2/intravenous dose in day hospital. Blood tests prior to the start of the appropriate chemotherapy cycle to receive acupuncture with continuous stimulation needle insertion: neutrophils greater or equal to 1000 cells/mm3 and platelets greater than or equal to 50,000 cells/mm3. Signature of informed consent by parents in the case of children under 12 years of age and assent of the minor. Signature of informed consent in the case of those over 12 years of age Exclusion Criteria: Participate in a clinical trial that is developed in the Pediatric Oncology Area of the Hospital Sant Joan de Deu where acupuncture intervention is not permitted. Have received acupuncture treatment in the last ten days. Receive concomitant abdominal radiotherapy. Have diarrhea on day 1 of the cycle
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Martinez, MD
Phone
+34 932532100
Ext
80524
Email
esther.martinez@sjd.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Martinez, MD
Organizational Affiliation
Hospital Sant Joan de Deu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sant Joan de Deu
City
Esplugues De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Martinez, MD
Phone
+34 9.2532100
Ext
80524
Email
esther.martinez@sjd.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility and Safety of Acupuncture in the Prevention of Late Irinotecan-related Diarrhea in Pediatric Patients

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