Clinical trial NCT02148159: Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer
Official title: Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm of Gastrointestinal Tract
Keywords: anorexia
cachexia
cancer
unintentional weigh loss
gastrointestinal tract
adults
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage weight change over 8 weeks between two arms
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Appetite change between two arms
timeFrame: up to 8 weeks
measure: physical functioning
timeFrame: up to 8 weeks
measure: body composition
timeFrame: up to 8 weeks
Other outcomes:
measure: Quality of life between two arms
timeFrame: up to 8 weeks
measure: biomarkers
timeFrame: weeks 1, 4 and 8 (three measurements)
measure: symptom experience
timeFrame: up to 8 weeks
Locations:
city: Gainesville
country: United States
facility: University of Florida Clinical Research Center (CRC)
state: Florida
Study officials:
affiliation: University of Florida
name: Saunjoo Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.