Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Not Applicable

Completed

• Conditions: Malignant Neoplasm of Gastrointestinal Tract

• Registration Number: NCT02148159
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Study Start: 2014-10
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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).

Trial Locations

Locations (1)

University of Florida Clinical Research Center (CRC); 🇺🇸 Gainesville, Florida, United States