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| Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00058851 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Massage Therapy for Breast Cancer-Related Lymphedema |
| Estimated Enrollment: | 88 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | May 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| University of Arizona | Recruiting |
| Tucson, Arizona, United States, 85724 | |
| Contact: Michael J. Bernas, MS 520-626-6118 michaelb@u.arizona.edu | |
| Contact: Marlys H. Witte, MD 520-626-6118 lymph@u.arizona.edu | |
| Principal Investigator: | Marlys Witte, MD | University of Arizona |
More Information
| Study ID Numbers: | R21 AT001326-01 |
| Study First Received: | April 14, 2003 |
| Last Updated: | January 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00058851 |
| Health Authority: | United States: Federal Government |
|
Manual lymph drainage Combined physiotherapy |
|
Lymphedema Lymphatic Diseases Skin Diseases |
Edema Breast Neoplasms Breast Diseases |
|
Neoplasms Neoplasms by Site |
