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Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Primary Purpose

Malignant Neoplasm of Gastrointestinal Tract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cachexia Acupuncture-A (Peace Classic Needles® )
General Acupuncture-B (Peace Classic Needles®)
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Neoplasm of Gastrointestinal Tract focused on measuring anorexia, cachexia, cancer, unintentional weigh loss, gastrointestinal tract, adults

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Florida Clinical Research Center (CRC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cachexia Acupuncture-A

General Acupuncture-B

Arm 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

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

Outcomes

Primary Outcome Measures

Percentage weight change over 8 weeks between two arms
Weight will be measured each visit (pounds).

Secondary Outcome Measures

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.
physical functioning
survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).
body composition
Small, non-invasive device (bioelectrical impedance analysis) like a miniature version of EKG will measure changes in body composition (numeric scale).

Full Information

First Posted
May 15, 2014
Last Updated
January 15, 2019
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02148159
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Gastrointestinal Tract
Keywords
anorexia, cachexia, cancer, unintentional weigh loss, gastrointestinal tract, adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cachexia Acupuncture-A
Arm Type
Experimental
Arm 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
Arm Title
General Acupuncture-B
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Cachexia Acupuncture-A (Peace Classic Needles® )
Other Intervention Name(s)
Acu-Market, Mechanism based acupuncture
Intervention Description
Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
Intervention Type
Device
Intervention Name(s)
General Acupuncture-B (Peace Classic Needles®)
Other Intervention Name(s)
Acu-Market, General acupuncture
Intervention Description
Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
Primary Outcome Measure Information:
Title
Percentage weight change over 8 weeks between two arms
Description
Weight will be measured each visit (pounds).
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Appetite change between two arms
Description
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.
Time Frame
up to 8 weeks
Title
physical functioning
Description
survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).
Time Frame
up to 8 weeks
Title
body composition
Description
Small, non-invasive device (bioelectrical impedance analysis) like a miniature version of EKG will measure changes in body composition (numeric scale).
Time Frame
up to 8 weeks
Other Pre-specified Outcome Measures:
Title
Quality of life between two arms
Description
Survey format includes the 27 items (5 points scale: 0 means 'not at all' and 4 means 'very much") .
Time Frame
up to 8 weeks
Title
biomarkers
Description
Small amounts of blood will be drawn.
Time Frame
weeks 1, 4 and 8 (three measurements)
Title
symptom experience
Description
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').
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saunjoo Yoon, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Clinical Research Center (CRC)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29971962
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.
Results Reference
derived

Learn more about this trial

Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

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