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

Study Overview
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Brief Summary
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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
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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

Official Title
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Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients: A Protocol for Double Blind Randomized Control Trial

Conditions
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Oral Cancer, Hypopharyngeal Cancer

Intervention / Treatment
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* Other: Specific acupuncture group
* Drug: Metoclopramide 10mg
* Other: Non-specific acupuncture group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups, randomized, pre-post intervention study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group: specific acupuncture group(Acu)<br>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. | Other: Specific acupuncture group<br>* 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.<br>* Other names: Specific acupuncture to treat indigestion;Drug: Metoclopramide 10mg<br>* 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.<br>* Other names: Metoclopramide 10mg/ per 8 hours in the case of poor digestion;|
| Placebo Comparator: Control group: non-specific acupuncture group (Con-Acu)<br>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 | Drug: Metoclopramide 10mg<br>* 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.<br>* Other names: Metoclopramide 10mg/ per 8 hours in the case of poor digestion;Other: Non-specific acupuncture group<br>* 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.<br>* Other names: Non specific acupuncture to treat indigestion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach Total Energy Expenditure | Number of days in takes for each patient to achieve the Total Energy Expenditure | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of prokinetic drugs prescribed | Secondary outcomes measures are the amount of prokinetic drugs prescribed by the ICU doctor in total dosage | Up to 1 month | 
| 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) | Up to 1 month | 
| 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 | up to 1 month | 
| Incidents of vomits | Incidents of vomits in total number of times and volume in micro liters | Up to 1 month | 
| Albumin blood levels | Patient's Albumin blood levels will help to assets patient's nutrition status | Up to 1 month | 
| Total ICU stay | Total ICU stay in days | Up to 23 month | 
| Total hospital stay | Total hospital stay in days | Up to 23 month | 
| Total mechanical ventilation in days | A day of mechanical ventilation is at least 6 hours of mechanical ventilation in one day | Up to 23 month | 
| Total mortality | In case of mortality ,total mortality will be compered between the two groups | Up to 23 month | 
| Incidents of diarrhea | Incidents of diarrhea in number of times and volume in micro liters | Up to 1 month | 
| Incidents of constipation | No stool passage in 3 days will be considered as constipation | Up to 1 month | 
| Incidents of nausea | Incidents of nausea in number of times , measured by patient complains | Up to 1 month | 
| Incidents of gastrointestinal bleeding | Positive occult blood test of the naso-gastric tube drainage and in the stool | Up to 1 month | 
| Incidents of fever episodes | Body temperature more than 38 degrees Celsius | Up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critically ill, Intensive care, Oral cancer, Hypo-pharyngeal cancer, Acupuncture, Digestion, ICU