The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers

Study Overview
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Brief Summary
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This trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.

Detailed Description
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Acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. The 160 eligibilities will be randomly divided into 3 groups(Acupuncture and Placebo group, Megestrol acetate and Sham Acupuncture group, Placebo and Sham Acupuncture group).The effect will be investigated baseline, the 2,5,8 and 15days. The safety issue will be recorded every section during the acupuncture.

Official Title
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The Traditional Chinese Medicine Department of Xin Qiao Hospital

Conditions
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Anorexia, Cancer Cachexia

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham Acupuncture
* Drug: Megestrol Acetate
* Drug: Placebo(Megestrol Acetate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed gastrointestinal tand lung cancers; Age ≥18 years; Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening; Had a history of weight loss ≥5% within 6 moths; Maintained oral intake; Signed the informed consent. Exclusion Criteria: Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation; Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ; Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism); Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide) Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture; Lifetime expected less than 3 months.

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture+Placebo<br>Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days. | Other: Acupuncture<br>* Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being.<br>* Other names: True acupuncture;Drug: Placebo(Megestrol Acetate)<br>* Starch pill manufactured to mimic Megestrol Acetate 160mg tablet<br>* Other names: Placebo Pill;|
| Active Comparator: Megestrol Acetate+Sham acupuncture<br>Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days . | Other: Sham Acupuncture<br>* Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders.<br>Drug: Megestrol Acetate<br>* Megestrol Acetate 160mg tablet<br>* Other names: Positive Drug;|
| Placebo Comparator: Placebo+Sham acupuncture<br>Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days . | Other: Sham Acupuncture<br>* Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders.<br>Drug: Placebo(Megestrol Acetate)<br>* Starch pill manufactured to mimic Megestrol Acetate 160mg tablet<br>* Other names: Placebo Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite Visual Analog Scale | The assessment will be done thirty minutes before meals. The participators should record the score of their appetite (0 to 100 mm) the higher scores reflect better symptom control. | Baseline, the days 8 and 15. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Council of Nutrition appetite questionnaire (CNAQ) | Ask the subjects to complete the questionnaire by circling the correct answers and then tally the results based upon the following numerical scale: a =1, b = 2, c = 3, d = 4, e = 5. The sum of the scores for the individual items constitutes the CNAQ score. CNAQ score ≤28 indicates significant risk of at least 5% weight loss within six months. | Baseline, the days 8 and 15. | 
| Caloric intake | The caloric intake will be assessed by the dietician. | Baseline, the days 8 and 15. | 
| Functional Assessment of Anorexia/Cachexia Therapy | Functional Assessment of Anorexia/Cachexia Therapy was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns. | Baseline, the days 8 and 15. | 
| Nutritional status | weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined | Baseline, the days 8 and 15. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Anorexia Cachexia Syndrome, Acupuncture, Megestrol acetate, Poor Appetite, Anorexia, Randomized Controlled Trial