Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer
NCT ID: NCT02148159
Last Updated: 2019-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2014-10-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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
Cachexia Acupuncture-A (Peace Classic Needles® )
Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
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
General Acupuncture-B (Peace Classic Needles®)
Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
Interventions
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Cachexia Acupuncture-A (Peace Classic Needles® )
Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
General Acupuncture-B (Peace Classic Needles®)
Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Saunjoo Yoon, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida Clinical Research Center (CRC)
Gainesville, Florida, United States
Countries
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References
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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.
Other Identifiers
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OCR14647
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201400340
Identifier Type: -
Identifier Source: org_study_id
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