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

Lymphedema Clinical Trial

Official title:

Massage Therapy for Breast Cancer-Related Lymphedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058851
• Other study ID #: R21AT001326-01
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2003
• Last updated: August 17, 2009
• Start date: January 2003
• Est. completion date: November 2007

Study information

• Verified date: August 2009
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

Intervention

Procedure:
• Manual lymph drainage

• Combined physiotherapy

• Compression bandaging

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume change