Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer
January 15, 2019 updated by: University of Florida
Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610-0219
- University of Florida Clinical Research Center (CRC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cachexia Acupuncture-A
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 |
Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
Other Names:
|
|
Sham Comparator: General Acupuncture-B
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 |
Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage weight change over 8 weeks between two arms
Time Frame: up to 8 weeks
|
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
Time Frame: 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.
|
up to 8 weeks
|
|
physical functioning
Time Frame: up to 8 weeks
|
survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).
|
up to 8 weeks
|
|
body composition
Time Frame: 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).
|
up to 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life between two arms
Time Frame: up to 8 weeks
|
Survey format includes the 27 items (5 points scale: 0 means 'not at all' and 4 means 'very much") .
|
up to 8 weeks
|
|
biomarkers
Time Frame: weeks 1, 4 and 8 (three measurements)
|
Small amounts of blood will be drawn.
|
weeks 1, 4 and 8 (three measurements)
|
|
symptom experience
Time Frame: 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').
|
up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saunjoo Yoon, PhD, University of Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
May 15, 2014
First Submitted That Met QC Criteria
May 27, 2014
First Posted (Estimate)
May 28, 2014
Study Record Updates
Last Update Posted (Actual)
January 17, 2019
Last Update Submitted That Met QC Criteria
January 15, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201400340
- OCR14647 (Other Identifier: University of Florida)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.