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Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients

Primary Purpose

Oral Cancer, Hypopharyngeal Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Specific acupuncture group
Metoclopramide 10mg
Non-specific acupuncture group
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cancer focused on measuring Critically ill, Intensive care, Oral cancer, Hypo-pharyngeal cancer, Acupuncture, Digestion, ICU

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 30-80
  • Apache score below 20
  • Patients needed EN
  • Post plastic surgery, including oral cancer or hypo-pharyngeal cancer

Exclusion Criteria:

  • Coagulopathy,
  • prolong prothrombin time (PPT) activated partial thromboplastin time (aPTT) more then 4 times
  • Thrombocytopenia - low platelet count
  • Clinically unstable: receiving two inotropic agents or Fraction of inspired Oxygen (FiO2) >70%
  • Estimated ICU stay - less than 3 days

Sites / Locations

  • surgical and burn intensive care departments and the plastic surgical department of China Medical University Hospital in Taichung city, Taiwan.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group: specific acupuncture group(Acu)

Control group: non-specific acupuncture group (Con-Acu)

Arm Description

In addition to routine ICU treatments, patients in the specific acupuncture group will also receive daily bilateral traditional Chinese medicine style acupuncture on the following acupuncture points: ST36 (Zu San Li), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Nei Guan) and LI4 (He Gu). The acupoints indications in this group are specific to treat indigestion related conditions. The treatment will take place once a day, over three days, for a total of three treatments. A total of 10 Needles will be used in each session Acupuncture treatment will be performed with sterile needles manufactured by "Yu Kuang" acupuncture needles 40mm with 30G. Acupuncture doctor will disinfect the acupoints with alcohol and will perform acupuncture on the marked points with needle Needle retention time will be 30 minutes. The needles will be withdrawn by acupuncture doctor.

Patients' in the non-specific acupuncture group (Con-Acu) will receive routine ICU treatment as well as a total of 3 daily non digestion related Traditional Chinese medicine style acupuncture treatments at the following acupoints: LI 15 (Jianyu), SJ 14 (JianLiao) LU3 (Tianfu), GB35 (Yangjiao), BL 59 (Fuyang). The selected control points are not indicated for the treatment of digestion related pathologies, and are not reported to improve digestive function. Acupuncture doctor 1 will disinfect the marked acupoints with alcohol and will perform acupuncture on the marked points. Needle retention time will be 30 minutes. The needles will be withdrawn by acupuncture doctor

Outcomes

Primary Outcome Measures

Time to reach Total Energy Expenditure
Number of days in takes for each patient to achieve the Total Energy Expenditure

Secondary Outcome Measures

Amount of prokinetic drugs prescribed
Secondary outcomes measures are the amount of prokinetic drugs prescribed by the ICU doctor in total dosage
The need of naso-jejunal feeding tube
After 5 days of conservative treatment for the poor digestion (naso-gastric tube drainage of more than 500ml per day or severe diarrhea of more than 1000 ml per day)
The need of parental nutrition
In patients who cannot digest with daily naso-gastric tube drainage of more than 500ml per day or severe diarrhea of more than 1000 ml per day
Incidents of vomits
Incidents of vomits in total number of times and volume in micro liters
Albumin blood levels
Patient's Albumin blood levels will help to assets patient's nutrition status
Total ICU stay
Total ICU stay in days
Total hospital stay
Total hospital stay in days
Total mechanical ventilation in days
A day of mechanical ventilation is at least 6 hours of mechanical ventilation in one day
Total mortality
In case of mortality ,total mortality will be compered between the two groups
Incidents of diarrhea
Incidents of diarrhea in number of times and volume in micro liters
Incidents of constipation
No stool passage in 3 days will be considered as constipation
Incidents of nausea
Incidents of nausea in number of times , measured by patient complains
Incidents of gastrointestinal bleeding
Positive occult blood test of the naso-gastric tube drainage and in the stool
Incidents of fever episodes
Body temperature more than 38 degrees Celsius

Full Information

First Posted
April 28, 2019
Last Updated
March 23, 2021
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03934294
Brief Title
Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients
Official Title
Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients: A Protocol for Double Blind Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
March 19, 2021 (Actual)
Study Completion Date
March 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

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

5. Study Description

Brief Summary
Background: Head and neck cancer patients are in high risk to suffer from malnourishment, a risk that increase in postoperative condition and with the use of enteral nutrition (EN). Until now patients who are suffering from indigestion in the ICU received treatment in the form of prokinetic drugs, drags that can lead to serious side effects and only can partially improve digestion. Acupuncture was used successfully in several clinical trials to improve postoperative indigestion in cancer patients without any reported adverse events. This study aims is to design a double blind settings in order to investigate acupuncture effect in combination of prokinetic drugs in the prevention of indigestion in postoperative oral and hypo-pharyngeal cancer patients in the Intensive Care Unit (ICU). Methods: Single center, double blind randomize control trial will compare between two equal groups. A total of 28 patients that will meet the inclusion criteria: Age 30-80, Post plastic surgery for oral cancer or hypo-pharyngeal cancer, Apache score below 20 needed EN. Patients will be randomly divided into specific acupuncture (ACU) or non-specific acupuncture (CON) for 3 treatments in 3 days by a blind acupuncturist along with prokinetic drugs. The main outcome measurement will be the amount of days a patient need to reach Total Energy Expenditure (TEE). Expected outcome: The results will shed light on the effectiveness and safety of acupuncture in a double blind design for posts-surgery ICU cancer patients. In addition, the study presents a revolutionary double blind design that if will prove as successful might influence the way double blind acupuncture studies are performed today.
Detailed Description
Background: Head and neck cancer patients are in high risk to suffer from malnourishment, a risk that increase in postoperative condition and with the use of enteral nutrition (EN). Until now patients who are suffering from indigestion in the ICU received treatment in the form of prokinetic drugs, drags that can lead to serious side effects and only can partially improve digestion. Acupuncture was used successfully in several clinical trials to improve postoperative indigestion in cancer patients without any reported adverse events. This study aims is to design a double blind settings in order to investigate acupuncture effect in combination of prokinetic drugs in the prevention of indigestion in postoperative oral and hypo-pharyngeal cancer patients in the Intensive Care Unit (ICU). Methods: Single center, double blind randomize control trial will compare between two equal groups. A total of 28 patients that will meet the inclusion criteria: Age 30-80, Post plastic surgery for oral cancer or hypo-pharyngeal cancer, Apache score below 20 needed EN. Patients will be randomly divided into specific acupuncture (ACU) or non-specific acupuncture (CON) for 3 treatments in 3 days by a blind acupuncturist along with prokinetic drugs. The main outcome measurement will be the amount of days a patient need to reach his Total Energy Expenditure (TEE). Expected outcome: The results will shed light on the effectiveness and safety of acupuncture in a double blind design for posts-surgery ICU cancer patients. In addition, the study presents a revolutionary double blind design that if will prove as successful might influence the way double blind acupuncture studies are performed today. Other information: The study will be conducted in the surgical ICU department, of china medical university hospital, Taichung 404, Taiwan. The study in conducted on stable ICU patients and is anticipated to have a minimum risk for adverse events. Patients enrollment and data collection will start immediately after china medical hospital research ethics committee approval. The study expected completion time: June 2021

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer, Hypopharyngeal Cancer
Keywords
Critically ill, Intensive care, Oral cancer, Hypo-pharyngeal cancer, Acupuncture, Digestion, ICU

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups, randomized, pre-post intervention study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients will be randomized to one of two groups: Acu/ Con in a 1:1 ratio. The random number and patient name will be written down on an non transparent envelope by a study nurse. The study nurse will provide an envelope containing a sheet depicting the acupoint name, location and picture (Acu / Con) to the acupuncture doctor. Acupuncture doctor (blind) will preform acupuncture on the points. 30 minutes after needle insertion, acupuncture doctor will withdraw the needles. Acupuncturists, ICU nurses, ICU doctors, researchers and statisticians will all be blind to group allocation and to the meaning of the random numbers until all acupuncture treatments have been completed.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group: specific acupuncture group(Acu)
Arm Type
Experimental
Arm Description
In addition to routine ICU treatments, patients in the specific acupuncture group will also receive daily bilateral traditional Chinese medicine style acupuncture on the following acupuncture points: ST36 (Zu San Li), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Nei Guan) and LI4 (He Gu). The acupoints indications in this group are specific to treat indigestion related conditions. The treatment will take place once a day, over three days, for a total of three treatments. A total of 10 Needles will be used in each session Acupuncture treatment will be performed with sterile needles manufactured by "Yu Kuang" acupuncture needles 40mm with 30G. Acupuncture doctor will disinfect the acupoints with alcohol and will perform acupuncture on the marked points with needle Needle retention time will be 30 minutes. The needles will be withdrawn by acupuncture doctor.
Arm Title
Control group: non-specific acupuncture group (Con-Acu)
Arm Type
Placebo Comparator
Arm Description
Patients' in the non-specific acupuncture group (Con-Acu) will receive routine ICU treatment as well as a total of 3 daily non digestion related Traditional Chinese medicine style acupuncture treatments at the following acupoints: LI 15 (Jianyu), SJ 14 (JianLiao) LU3 (Tianfu), GB35 (Yangjiao), BL 59 (Fuyang). The selected control points are not indicated for the treatment of digestion related pathologies, and are not reported to improve digestive function. Acupuncture doctor 1 will disinfect the marked acupoints with alcohol and will perform acupuncture on the marked points. Needle retention time will be 30 minutes. The needles will be withdrawn by acupuncture doctor
Intervention Type
Other
Intervention Name(s)
Specific acupuncture group
Other Intervention Name(s)
Specific acupuncture to treat indigestion
Intervention Description
In addition to routine ICU treatments, patients in the specific acupuncture group will also receive daily bilateral traditional Chinese medicine style acupuncture on the following acupuncture points: ST36 (Zu San Li), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Nei Guan) and LI4 (He Gu). The acupoints indications in this group are specific to treat indigestion related conditions. The treatment will take place once a day, over three days, for a total of three treatments. A total of 10 Needles will be used in each session Acupuncture treatment will be performed with sterile needles manufactured by "Yu Kuang" acupuncture needles 40mm with 30G.
Intervention Type
Drug
Intervention Name(s)
Metoclopramide 10mg
Other Intervention Name(s)
Metoclopramide 10mg/ per 8 hours in the case of poor digestion
Intervention Description
Patients in all groups will receive Metoclopramide 10mg/ per 8 hours in the case of poor digestion, alongside the individualized drug treatment prescribed by the ICU medical doctor as per individual patient needs.
Intervention Type
Other
Intervention Name(s)
Non-specific acupuncture group
Other Intervention Name(s)
Non specific acupuncture to treat indigestion
Intervention Description
Patients' in the non-specific acupuncture group (Con-Acu) will receive routine ICU treatment as well as a total of 3 daily non digestion related Traditional Chinese medicine style acupuncture treatments at the following acupoints: LI 15 (Jianyu), SJ 14 (JianLiao) LU3 (Tianfu), GB35 (Yangjiao), BL 59 (Fuyang). The selected control points are not indicated for the treatment of digestion related conditions, and are not reported to improve digestive function.
Primary Outcome Measure Information:
Title
Time to reach Total Energy Expenditure
Description
Number of days in takes for each patient to achieve the Total Energy Expenditure
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Amount of prokinetic drugs prescribed
Description
Secondary outcomes measures are the amount of prokinetic drugs prescribed by the ICU doctor in total dosage
Time Frame
Up to 1 month
Title
The need of naso-jejunal feeding tube
Description
After 5 days of conservative treatment for the poor digestion (naso-gastric tube drainage of more than 500ml per day or severe diarrhea of more than 1000 ml per day)
Time Frame
Up to 1 month
Title
The need of parental nutrition
Description
In patients who cannot digest with daily naso-gastric tube drainage of more than 500ml per day or severe diarrhea of more than 1000 ml per day
Time Frame
up to 1 month
Title
Incidents of vomits
Description
Incidents of vomits in total number of times and volume in micro liters
Time Frame
Up to 1 month
Title
Albumin blood levels
Description
Patient's Albumin blood levels will help to assets patient's nutrition status
Time Frame
Up to 1 month
Title
Total ICU stay
Description
Total ICU stay in days
Time Frame
Up to 23 month
Title
Total hospital stay
Description
Total hospital stay in days
Time Frame
Up to 23 month
Title
Total mechanical ventilation in days
Description
A day of mechanical ventilation is at least 6 hours of mechanical ventilation in one day
Time Frame
Up to 23 month
Title
Total mortality
Description
In case of mortality ,total mortality will be compered between the two groups
Time Frame
Up to 23 month
Title
Incidents of diarrhea
Description
Incidents of diarrhea in number of times and volume in micro liters
Time Frame
Up to 1 month
Title
Incidents of constipation
Description
No stool passage in 3 days will be considered as constipation
Time Frame
Up to 1 month
Title
Incidents of nausea
Description
Incidents of nausea in number of times , measured by patient complains
Time Frame
Up to 1 month
Title
Incidents of gastrointestinal bleeding
Description
Positive occult blood test of the naso-gastric tube drainage and in the stool
Time Frame
Up to 1 month
Title
Incidents of fever episodes
Description
Body temperature more than 38 degrees Celsius
Time Frame
Up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 30-80 Apache score below 20 Patients needed EN Post plastic surgery, including oral cancer or hypo-pharyngeal cancer Exclusion Criteria: Coagulopathy, prolong prothrombin time (PPT) activated partial thromboplastin time (aPTT) more then 4 times Thrombocytopenia - low platelet count Clinically unstable: receiving two inotropic agents or Fraction of inspired Oxygen (FiO2) >70% Estimated ICU stay - less than 3 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Yu Kao, M.D.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
surgical and burn intensive care departments and the plastic surgical department of China Medical University Hospital in Taichung city, Taiwan.
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40402
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients

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