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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00058851
First Posted: April 15, 2003
Last Update Posted: August 19, 2009
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.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Massage Therapy for Breast Cancer-Related Lymphedema

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00058851


Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Michael J Bernas, MS University of Arizona
  More Information

ClinicalTrials.gov Identifier: NCT00058851     History of Changes
Other Study ID Numbers: R21AT001326-01 ( U.S. NIH Grant/Contract )
First Submitted: April 14, 2003
First Posted: April 15, 2003
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:
Lymphedema
Breast Cancer Lymphedema
Lymphatic Diseases
Postoperative Complications
Pathologic Processes