Malignant Neoplasm of Gastrointestinal Tract
Conditions
Keywords
anorexia, cachexia, cancer, unintentional weigh loss, gastrointestinal tract, adults
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.
Interventions
DEVICECachexia Acupuncture-A (Peace Classic Needles® )
Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
DEVICEGeneral Acupuncture-B (Peace Classic Needles®)
Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage weight change over 8 weeks between two arms | up to 8 weeks | Weight will be measured each visit (pounds). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| physical functioning | up to 8 weeks | survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning). |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| biomarkers | weeks 1, 4 and 8 (three measurements) | Small amounts of blood will be drawn. |
| symptom experience | up to 8 weeks | Survey format: 13 areas related to the symptom experience and patient's concerns will be assessed (4 points scale; 0 means 'not at all' and 3 means 'very much'). |
| Quality of life between two arms | up to 8 weeks | Survey format includes the 27 items (5 points scale: 0 means 'not at all' and 4 means 'very much) . |
Countries
United States
Outcome results
None listed