Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Malignant Neoplasm of Gastrointestinal Tract Clinical Trial

Official title:

Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148159
• Other study ID #: IRB201400340
• Secondary ID: OCR14647
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: January 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Malignant Neoplasm of Gastrointestinal Tract
• Neoplasms
• Weight Loss

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Florida Clinical Research Center (CRC)	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life between two arms	Survey format includes the 27 items (5 points scale: 0 means 'not at all' and 4 means 'very much") .	up to 8 weeks
Other	biomarkers	Small amounts of blood will be drawn.	weeks 1, 4 and 8 (three measurements)
Other	symptom experience	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
Primary	Percentage weight change over 8 weeks between two arms	Weight will be measured each visit (pounds).	up to 8 weeks
Secondary	Appetite change between two arms	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
Secondary	physical functioning	survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).	up to 8 weeks
Secondary	body composition	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