Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Study Overview
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Brief Summary
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Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid weight loss negatively impact on physical functioning, quality of life, and overall survival. Patients will be randomly assigned into two groups. An intervention with acupuncture may slow down or stop the progression of cancer-related anorexia and weight loss.

Detailed Description
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The purpose of this research study is to investigate if acupuncture helps to improve appetite and slow down unintentional weight loss. The participants will be randomly divided into two groups and receive 8 sessions of acupuncture (two groups will receive different acupuncture points) for 8 weeks. During the study period, participants will be asked various questions about appetite, physical functioning, cancer-related symptoms and quality of life to understand changes related to body weight, as well as blood samples. The research team members will collect data regarding changes in appetite, body weight, body composition, and physical functioning.

Official Title
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Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia

Conditions
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Malignant Neoplasm of Gastrointestinal Tract

Intervention / Treatment
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* Device: Cachexia Acupuncture-A (Peace Classic Needles® )
* Device: General Acupuncture-B (Peace Classic Needles®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 year or older medical diagnosis of gastrointestinal cancer (for example, gastric, biliary, or colorectal) experienced weight loss of at least 5% over the last 6 months ability to communicate in English ability to follow the research protocol Exclusion Criteria: plan to have surgical procedures at the time of recruitment receive radiation therapy alone or in addition to chemotherapy during the study period undergo surgery during the study or in the months prior to the study no plan to have chemotherapy after the surgery any comorbidities that may affect the interpretation of study findings open burn sites or infected wounds esophageal cancer or pancreatic cancer life expectancy of less than 6 months as assessed by attending physician

Ages Eligible for Study
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Minimum Age: 21 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cachexia Acupuncture-A<br>Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points that are selected based on the potential mechanisms of cachexia. Intervention will be done by a licensed acupuncturist who has over 5 years of experience as an independent clinician and has experience particularly in the management of cancer related symptoms. Acupuncture treatment will consist of 8 sessions over 8 week period. Acupuncture needles: Single-use, sterile stainless steel and disposable [acupuncture needles-Peace Classic Needles®, Acu-Market] Other name: Mechanism based acupuncture | Device: Cachexia Acupuncture-A (Peace Classic Needles® )<br>* Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.<br>* Other names: Mechanism based acupuncture;|
| Sham Comparator: General Acupuncture-B<br>General Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points. These points are the real acupuncture points; however, these points are not specific to cachexia management. Participants will receive the acupuncture treatment over 8 weeks (total of 8 sessions) in the same manner as the experimental group; the only difference will be the place(type) and number of points targeted. Acupuncture needles: single-use, sterile stainless steel and disposable needles [Peace Classic Needles®, Acu-Market] Other name: General acupuncture | Device: General Acupuncture-B (Peace Classic Needles®)<br>* Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.<br>* Other names: General acupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage weight change over 8 weeks between two arms | Weight will be measured each visit (pounds). | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite change between two arms | Three different short survey forms will be used to measure appetite change. Visual analogue scale (0 indicates no appetite and 10 is the best appetite). Simplified Nutritional Appetite Questionnaire score (min-max: 4-20 and the higher the better appetite) Patient Generated Subjective Global Assessment: 0-1, no intervention is needed. 9 or higher score indicates critical intervention. | up to 8 weeks | 
| physical functioning | survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning). | up to 8 weeks | 
| body composition | Small, non-invasive device (bioelectrical impedance analysis) like a miniature version of EKG will measure changes in body composition (numeric scale). | up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorexia, cachexia, cancer, unintentional weigh loss, gastrointestinal tract, adults