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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00058851
Recruitment Status : Completed
First Posted : April 15, 2003
Last Update Posted : August 19, 2009
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphedema Procedure: Manual lymph drainage Procedure: Combined physiotherapy Procedure: Compression bandaging Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Massage Therapy for Breast Cancer-Related Lymphedema
Study Start Date : January 2003
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Primary Outcome Measures :
  1. volume change

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00058851

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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Michael J Bernas, MS University of Arizona
Layout table for additonal information Identifier: NCT00058851    
Other Study ID Numbers: R21AT001326-01 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2003    Key Record Dates
Last Update Posted: August 19, 2009
Last Verified: August 2009
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Manual lymph drainage
Combined physiotherapy
Additional relevant MeSH terms:
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Lymphatic Diseases