Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

University of Florida

Status: Completed

Conditions: Malignant Neoplasm of Gastrointestinal Tract

Treatments: Device: General Acupuncture-B (Peace Classic Needles®); Device: Cachexia Acupuncture-A (Peace Classic Needles® )

Study type: Interventional

Funder types: Other

Identifiers

NCT02148159

IRB201400340

OCR14647 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Cachexia Acupuncture-A

Experimental group

Description:

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

Treatment:

Device: Cachexia Acupuncture-A (Peace Classic Needles® )

General Acupuncture-B

Sham Comparator group

Description:

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

Treatment:

Device: General Acupuncture-B (Peace Classic Needles®)