Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

January 15, 2019 updated by: University of Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610-0219
        • University of Florida Clinical Research Center (CRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Cachexia Acupuncture-A (Peace Classic Needles® )
Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
Other Names:
  • Acu-Market
  • Mechanism based acupuncture
Sham Comparator: 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
Device: General Acupuncture-B (Peace Classic Needles®)
Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
Other Names:
  • Acu-Market
  • General acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage weight change over 8 weeks between two arms
Time Frame: up to 8 weeks
Weight will be measured each visit (pounds).
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite change between two arms
Time Frame: up to 8 weeks
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
physical functioning
Time Frame: up to 8 weeks
survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).
up to 8 weeks
body composition
Time Frame: up to 8 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life between two arms
Time Frame: up to 8 weeks
Survey format includes the 27 items (5 points scale: 0 means 'not at all' and 4 means 'very much") .
up to 8 weeks
biomarkers
Time Frame: weeks 1, 4 and 8 (three measurements)
Small amounts of blood will be drawn.
weeks 1, 4 and 8 (three measurements)
symptom experience
Time Frame: up to 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Saunjoo Yoon, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400340
  • OCR14647 (Other Identifier: University of Florida)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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