Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer
Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia
2 other identifiers
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2014
CompletedFirst Posted
Study publicly available on registry
May 28, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJanuary 17, 2019
January 1, 2019
1.6 years
May 15, 2014
January 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage weight change over 8 weeks between two arms
Weight will be measured each visit (pounds).
up to 8 weeks
Secondary Outcomes (3)
Appetite change between two arms
up to 8 weeks
physical functioning
up to 8 weeks
body composition
up to 8 weeks
Other Outcomes (3)
Quality of life between two arms
up to 8 weeks
biomarkers
weeks 1, 4 and 8 (three measurements)
symptom experience
up to 8 weeks
Study Arms (2)
Cachexia Acupuncture-A
EXPERIMENTALAcupuncture-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
General Acupuncture-B
SHAM COMPARATORGeneral 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
Interventions
Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida Clinical Research Center (CRC)
Gainesville, Florida, 32610-0219, United States
Related Publications (1)
Yoon SL, Grundmann O, Williams JJ, Gordan L, George TJ Jr. Body composition changes differ by gender in stomach, colorectal, and biliary cancer patients with cachexia: Results from a pilot study. Cancer Med. 2018 Aug;7(8):3695-3703. doi: 10.1002/cam4.1665. Epub 2018 Jul 3.
PMID: 29971962DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saunjoo Yoon, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2014
First Posted
May 28, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
January 17, 2019
Record last verified: 2019-01