Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

NCT ID: NCT02148159

Last Updated: 2019-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Malignant Neoplasm of Gastrointestinal Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Cachexia Acupuncture-A (Peace Classic Needles® )

Intervention Type DEVICE

Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.

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

Group Type SHAM_COMPARATOR

General Acupuncture-B (Peace Classic Needles®)

Intervention Type DEVICE

Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.

Interventions

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Cachexia Acupuncture-A (Peace Classic Needles® )

Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.

Intervention Type DEVICE

General Acupuncture-B (Peace Classic Needles®)

Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.

Intervention Type DEVICE

Other Intervention Names

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Acu-Market Mechanism based acupuncture Acu-Market General acupuncture

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saunjoo Yoon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida Clinical Research Center (CRC)

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29971962 (View on PubMed)

Other Identifiers

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OCR14647

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201400340

Identifier Type: -

Identifier Source: org_study_id

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