An interventional study of Cachexia Acupuncture-A (Peace Classic Needles® ) and General Acupuncture-B (Peace Classic Needles®) in Malignant Neoplasm of Gastrointestinal Tract, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-01-17.
Sponsored by University of Florida · Not applicable, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
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® )
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®)
Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
Also known as: Acu-Market, Mechanism based acupuncture
Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
Also known as: Acu-Market, General acupuncture
Percentage weight change over 8 weeks between two arms
Weight will be measured each visit (pounds).
Time frame: up to 8 weeks
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.
Time frame: up to 8 weeks
physical functioning
survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).
Time frame: 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).
Time frame: up to 8 weeks
Quality of life between two arms
Survey format includes the 27 items (5 points scale: 0 means 'not at all' and 4 means 'very much") .
Time frame: up to 8 weeks
biomarkers
Small amounts of blood will be drawn.
Time frame: weeks 1, 4 and 8 (three measurements)
symptom experience
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').
Time frame: up to 8 weeks
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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