Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02148159

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Neoplasm of Gastrointestinal Tract	Device: Cachexia Acupuncture-A (Peace Classic Needles® ) Device: General Acupuncture-B (Peace Classic Needles®)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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