Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Not Applicable

Completed

Interventions: Device: General Acupuncture-B (Peace Classic Needles®)
Device: Cachexia Acupuncture-A (Peace Classic Needles® )

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
General Acupuncture-B	General Acupuncture-B (Peace Classic Needles®)	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
Cachexia Acupuncture-A	Cachexia Acupuncture-A (Peace Classic Needles® )	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

Primary Outcome Measures

Name	Time	Method
Percentage weight change over 8 weeks between two arms	up to 8 weeks	Weight will be measured each visit (pounds).

Secondary Outcome Measures

Name	Time	Method
Appetite change between two arms	up to 8 weeks	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.
body composition	up to 8 weeks	Small, non-invasive device (bioelectrical impedance analysis) like a miniature version of EKG will measure changes in body composition (numeric scale).
physical functioning	up to 8 weeks	survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).

Locations (1): University of Florida Clinical Research Center (CRC)
🇺🇸
Gainesville, Florida, United States