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Electric Stimulation on Nausea and Vomit Chemotherapy Induced (TENS-NV)

Primary Purpose

Breast Cancer Female, Acupuncture

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Placebo Group
Low Frequency Group
High Frequency Group
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring Chemotherapy, nausea, vomiting, transcutaneous electrical acupoint stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Having breast cancer diagnosed through anatomopathological investigation;
  • Indication of neoadjuvant or adjuvant chemotherapy treatment with the combination of anthracycline and cyclophosphamide associated with Ondasetron used as a routine of the Santa Rita Hospital chemotherapy service;
  • Present Karnofsky score (KPS) higher than 70 points;
  • Being female;
  • Be between 18 and 65 years of age and be able to participate in outpatient chemotherapy.

Exclusion Criteria:

  • Patients with breast cancer treated with chemotherapeutic regimens other than anthracycline and cyclophosphamide;
  • Inability to report nausea and vomiting due to neurological changes, difficulty understanding and / or lack of caregivers that may contribute to the completion of the report;
  • Be submitted to radiation therapy concomitant with chemotherapy;
  • Presence of gastrointestinal and cerebral metastases;
  • Presence of cardiac pacemaker;
  • Presence of active skin infection in PC6;
  • Nausea and vomiting caused by electrolyte disturbances or intestinal;
  • Presence of intra-cranial hypertension.

Sites / Locations

  • Fabrício Edler MacagnanRecruiting
  • Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo Group

Low Frequency Group

High Frequency Group

Arm Description

Placebo Group: In this group the participants received TENS with frequency of 75Hz, pulse duration of 200 microseconds. The stimulation time will be for only 10s.

Low Frequency Group: In this group the TENS will be adjusted with frequency of 10Hz, pulse duration of 200 microseconds. The stimulation time will be 30 minutes and the intensity will be constantly adjusted in order to keep as high as possible within the tolerance threshold of the patient.

High Frequency Group: In this group the TENS will be adjusted with frequency of 150Hz, pulse duration of 200 microseconds. The stimulation time will be 30 minutes and the intensity will be constantly adjusted in order to keep as high as possible within the tolerance threshold of the patient.

Outcomes

Primary Outcome Measures

Cumulative index of nausea
The 24-hour follow-up record of symptoms of nausea and vomiting will be performed using a form developed from the MASEM anti-emetic instrument (MAT), especially for the present study. This form includes a diary to record emetic events within 24 hours after the administration of chemotherapy. Thus, we will evaluate: the cumulative index of nausea and vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy.Participants will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the investigators when they return to the outpatient clinic for another round of chemotherapy.

Secondary Outcome Measures

Cumulative index of episodes of vomiting
The 24-hour follow-up record of symptoms of nausea and vomiting will be performed using a form developed from the MASEM anti-emetic instrument (MAT), especially for the present study. This form includes a diary to record emetic events within 24 hours after the administration of chemotherapy. Thus, we will evaluate: the cumulative index of nausea and vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy.Participants will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the investigators when they return to the outpatient clinic for another round of chemotherapy.
Intensity of nausea symptoms
As for the intensity of nausea, a Visual Analog Scale will be used to help measure the intensity of each patient. The instrument will question the patient about the degree of nausea and it will provide an auto report with a note that can vary from 0 to 10, with note 0 representing absence of the symptom while note 10 represents the most intense sensation experienced by the patient . Participants will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the investigators when they return to the outpatient clinic for another round of chemotherapy.
Severity of vomiting episodes
The severity assessment of vomiting episodes includes a diary to record the number of episodes of vomiting, which may be small, medium or large. Thus, we will assess the severity of vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy. Participants will be instructed to complete the instrument and take the questionnaire home, bringing it back to the investigators. When they return to the clinic for another round of chemotherapy.
Need for rescue antiemetic
The 24-hour follow-up record of symptoms of nausea and vomiting will be performed using a form developed from the MASEM anti-emetic instrument (MAT), especially for the present study. This form includes a diary to record emetic events within 24 hours after the administration of chemotherapy. Thus, we will evaluate: the cumulative index of nausea and vomiting over 24 hours after the infusion of the first cycle of emetic high-grade chemotherapy, the volume of vomiting in each episode and the need for rescue antiemetics will also be recorded. Will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the researchers when they return to the clinic for their second course of chemotherapy.
Edmonton Symptom Assessment Scale
At home and at the end of 24 hours, will be asked to fill in the Edmonton Symptom Assessment Scale where symptoms of pain, tiredness, drowsiness, appetite, nausea, shortness of breath, depression, anxiety and well-being will be evaluated, Based on the Brazilian Consensus on Nausea and Vomiting. It is a scale where the patient provides an auto-report with a note that can vary from 0 to 10, with note 0 representing absence of the symptom while note 10 represents the most intense sensation experienced by the patient.

Full Information

First Posted
May 5, 2017
Last Updated
August 21, 2017
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03145727
Brief Title
Electric Stimulation on Nausea and Vomit Chemotherapy Induced
Acronym
TENS-NV
Official Title
Transcutaneous Electric Nerve Stimulation Effects on Nausea and Vomit Chemotherapy-induced
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Anticipated)
Study Completion Date
October 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Chemotherapy induces nausea and vomit for some large patients. But, some chemotherapy protocol has a high indices of the incidence as observed in a combination of Anthracycline and Cyclophosphamide (AC). To prevent this symptoms, some medication can be used as Ondansetron. By other hands, the traditional acupuncture on Chinese Medicine have been used a PC6 point to avoid nausea and vomit. More recently, a transcutaneous electric nerve stimulation (TENS) also has been used for this application. Our study will test the TENS applied on PC6 point with two different frequencies (high and low) to evaluated the nausea and vomit inhibition effects.
Detailed Description
We will enroll 84 women that being starts a chemotherapy protocol with a Anthracycline and Cyclophosphamide (AC) as a part of breast cancer treatment. All volunteers will be submitted a 30 minutes TENS prior to chemotherapy administration. Three different TENS treatment will be test: 1) placebo; 2) high frequency and 3) low frequency. The self-adhesive electrodes will be positioned in the same position for all different TENS treatment (opposite arm to the chemotherapy infusion). The eletctrodes will be positioned as follows: the first electrode at the PC6 point which is located proximal to the flexion fold of the wrist in the middle of the anterior face of the forearm, between the tendons of the long palmar and radial flexor muscles of the carpus and the second electrode at any point in the hand. After that, all volunteers will receipt a formulary to self-complete a nausea and vomit symptoms record during the next 24 hours. Number of incidence and magnitude of the symptoms will express the accumulated indices the occurrence and severity of the symptoms, as further describe in this protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Acupuncture
Keywords
Chemotherapy, nausea, vomiting, transcutaneous electrical acupoint stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The selection of the investigated will be characterized as non-probabilistic with a convenience approach, whose patients will be included in the study sequentially until the necessary sizing has been achieved. Patients will be included sequentially for convenience (according to the inclusion and exclusion criteria) and non-probabilistic. The included individuals will be randomly randomized by Random Allocation System software in three groups, 1) placebo group; 2) High Frequency Group; 3) Low Frequency Group.
Masking
Participant
Masking Description
The participant will be blind to the TENS allocation.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo Group: In this group the participants received TENS with frequency of 75Hz, pulse duration of 200 microseconds. The stimulation time will be for only 10s.
Arm Title
Low Frequency Group
Arm Type
Experimental
Arm Description
Low Frequency Group: In this group the TENS will be adjusted with frequency of 10Hz, pulse duration of 200 microseconds. The stimulation time will be 30 minutes and the intensity will be constantly adjusted in order to keep as high as possible within the tolerance threshold of the patient.
Arm Title
High Frequency Group
Arm Type
Experimental
Arm Description
High Frequency Group: In this group the TENS will be adjusted with frequency of 150Hz, pulse duration of 200 microseconds. The stimulation time will be 30 minutes and the intensity will be constantly adjusted in order to keep as high as possible within the tolerance threshold of the patient.
Intervention Type
Device
Intervention Name(s)
Placebo Group
Intervention Description
In this group, the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the opposite arm of the chemotherapy infusion, but in this group the electrical stimulation will be performed just by 10 seconds and turn off for all reminiscent time of the protocol.
Intervention Type
Device
Intervention Name(s)
Low Frequency Group
Intervention Description
In this group the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the arm opposite the chemotherapy infusion. The electrical stimulation will be continued for all time secession. The electrical pulse parameters will be setting according describe early.
Intervention Type
Device
Intervention Name(s)
High Frequency Group
Intervention Description
In this group the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the arm opposite the chemotherapy infusion. The electrical stimulation will be continued for all time secession. The electrical pulse parameters will be setting according describe early.
Primary Outcome Measure Information:
Title
Cumulative index of nausea
Description
The 24-hour follow-up record of symptoms of nausea and vomiting will be performed using a form developed from the MASEM anti-emetic instrument (MAT), especially for the present study. This form includes a diary to record emetic events within 24 hours after the administration of chemotherapy. Thus, we will evaluate: the cumulative index of nausea and vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy.Participants will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the investigators when they return to the outpatient clinic for another round of chemotherapy.
Time Frame
Cumulative index of nausea in the first 24 hours after an infusion of chemotherapy.
Secondary Outcome Measure Information:
Title
Cumulative index of episodes of vomiting
Description
The 24-hour follow-up record of symptoms of nausea and vomiting will be performed using a form developed from the MASEM anti-emetic instrument (MAT), especially for the present study. This form includes a diary to record emetic events within 24 hours after the administration of chemotherapy. Thus, we will evaluate: the cumulative index of nausea and vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy.Participants will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the investigators when they return to the outpatient clinic for another round of chemotherapy.
Time Frame
Cumulative index of episodes of vomiting in the first 24 hours after an infusion of chemotherapy.
Title
Intensity of nausea symptoms
Description
As for the intensity of nausea, a Visual Analog Scale will be used to help measure the intensity of each patient. The instrument will question the patient about the degree of nausea and it will provide an auto report with a note that can vary from 0 to 10, with note 0 representing absence of the symptom while note 10 represents the most intense sensation experienced by the patient . Participants will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the investigators when they return to the outpatient clinic for another round of chemotherapy.
Time Frame
Intensity of the symptom of nausea within the first 24 hours after infusion of chemotherapy.
Title
Severity of vomiting episodes
Description
The severity assessment of vomiting episodes includes a diary to record the number of episodes of vomiting, which may be small, medium or large. Thus, we will assess the severity of vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy. Participants will be instructed to complete the instrument and take the questionnaire home, bringing it back to the investigators. When they return to the clinic for another round of chemotherapy.
Time Frame
Severity of vomiting episodes within the first 24 hours after chemotherapy infusion.
Title
Need for rescue antiemetic
Description
The 24-hour follow-up record of symptoms of nausea and vomiting will be performed using a form developed from the MASEM anti-emetic instrument (MAT), especially for the present study. This form includes a diary to record emetic events within 24 hours after the administration of chemotherapy. Thus, we will evaluate: the cumulative index of nausea and vomiting over 24 hours after the infusion of the first cycle of emetic high-grade chemotherapy, the volume of vomiting in each episode and the need for rescue antiemetics will also be recorded. Will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the researchers when they return to the clinic for their second course of chemotherapy.
Time Frame
Need for rescue antiemetic within the first 24 hours after chemotherapy infusion
Title
Edmonton Symptom Assessment Scale
Description
At home and at the end of 24 hours, will be asked to fill in the Edmonton Symptom Assessment Scale where symptoms of pain, tiredness, drowsiness, appetite, nausea, shortness of breath, depression, anxiety and well-being will be evaluated, Based on the Brazilian Consensus on Nausea and Vomiting. It is a scale where the patient provides an auto-report with a note that can vary from 0 to 10, with note 0 representing absence of the symptom while note 10 represents the most intense sensation experienced by the patient.
Time Frame
At the end of 24 hours, you will be asked to complete the Edmonton Symptom Assessment Scale

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with indication for neoadjuvant or adjuvant chemotherapy treatment with the combination of anthracycline and cyclophosphamide associated with Ondasetron
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having breast cancer diagnosed through anatomopathological investigation; Indication of neoadjuvant or adjuvant chemotherapy treatment with the combination of anthracycline and cyclophosphamide associated with Ondasetron used as a routine of the Santa Rita Hospital chemotherapy service; Present Karnofsky score (KPS) higher than 70 points; Being female; Be between 18 and 65 years of age and be able to participate in outpatient chemotherapy. Exclusion Criteria: Patients with breast cancer treated with chemotherapeutic regimens other than anthracycline and cyclophosphamide; Inability to report nausea and vomiting due to neurological changes, difficulty understanding and / or lack of caregivers that may contribute to the completion of the report; Be submitted to radiation therapy concomitant with chemotherapy; Presence of gastrointestinal and cerebral metastases; Presence of cardiac pacemaker; Presence of active skin infection in PC6; Nausea and vomiting caused by electrolyte disturbances or intestinal; Presence of intra-cranial hypertension.
Facility Information:
Facility Name
Fabrício Edler Macagnan
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrício Macagnan, PhD
Phone
+55 (51) 3309.8876
Email
fabriciom@ufcspa.edu.br
Facility Name
Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizete Keitel, Dr
Phone
+55 (51) 3214.8571
Email
cep@santacasa.tche.br

12. IPD Sharing Statement

Plan to Share IPD
No

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Electric Stimulation on Nausea and Vomit Chemotherapy Induced

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