Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms

This study has been completed.

Sponsor:

Information provided by:

National Center for Complementary and Alternative Medicine (NCCAM)

ClinicalTrials.gov Identifier:

NCT00058851

First received: April 14, 2003

Last updated: August 17, 2009

Last verified: August 2009

History of Changes

Purpose

The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs.

Condition	Intervention	Phase
Lymphedema	Procedure: Manual lymph drainage Procedure: Combined physiotherapy Procedure: Compression bandaging	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Massage Therapy for Breast Cancer-Related Lymphedema

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Edema Lymphedema

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

volume change

Estimated Enrollment:	88
Study Start Date:	January 2003
Study Completion Date:	November 2007

Detailed Description:

Massage therapy (in the form of manual lymph drainage [MLD]) and compression bandaging (CB) are integral components of combined physical therapy (CPT), the recommended treatment for peripheral lymphedema (LE). According to the World Health Organization, LE afflicts hundreds of millions worldwide and probably millions in the United States. Effects of various forms of massage on lymph circulation have been postulated for more than a century, but the efficacy of MLD alone without CB has not been demonstrated. New data suggest that MLD alone reduces established LE volume as effectively as CB in combination with CPT and minimizes LE development.

Patients will be randomly assigned to either treatment with MLD alone or a combination of MLD and CB. Patients will be treated in 10 one-hour sessions over 2 weeks. They will also undergo lymphangioscintigraphy (a nuclear medicine test) to depict the function of their lymphatic system. Patients will continue self treatment at home and will be followed for 6 months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Lymphedema (5% to 20% increase in volume) after breast cancer treatment

Exclusion Criteria:

Physically unable to perform massage or bandaging during home program

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058851

Locations

United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Michael J Bernas, MS

University of Arizona

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00058851 History of Changes
Other Study ID Numbers:	R21 AT001326-01
Study First Received:	April 14, 2003
Last Updated:	August 17, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Manual lymph drainage
Combined physiotherapy

Additional relevant MeSH terms:

Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms

Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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