Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms
Primary Purpose
Lymphedema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Manual lymph drainage
Combined physiotherapy
Compression bandaging
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema focused on measuring Manual lymph drainage, Combined physiotherapy
Eligibility 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
Sites / Locations
- University of Arizona
Outcomes
Primary Outcome Measures
volume change
Secondary Outcome Measures
Full Information
NCT ID
NCT00058851
First Posted
April 14, 2003
Last Updated
August 17, 2009
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00058851
Brief Title
Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms
Official Title
Massage Therapy for Breast Cancer-Related Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
Manual lymph drainage, Combined physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Manual lymph drainage
Intervention Type
Procedure
Intervention Name(s)
Combined physiotherapy
Intervention Type
Procedure
Intervention Name(s)
Compression bandaging
Primary Outcome Measure Information:
Title
volume change
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Bernas, MS
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
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Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms
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