Viewing Study NCT00058851



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Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00058851
Status: COMPLETED
Last Update Posted: 2009-08-19
First Post: 2003-04-14

Brief Title: Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms
Sponsor: National Center for Complementary and Integrative Health NCCIH
Organization: National Center for Complementary and Integrative Health NCCIH

Study Overview

Official Title: Massage Therapy for Breast Cancer-Related Lymphedema
Status: COMPLETED
Status Verified Date: 2009-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None