Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY"
NCT00201890 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103
Last updated 2012-10-10
Summary
The purpose of this study is to evaluate the efficacy, safety and impact on quality of life of decongestive lymphatic therapy (DLT) in women who have completed treatment for breast cancer and present with lymphedema.
This is a multicentre trial enrolling 100 patients randomized to receive conservative care for arm lymphedema (Canadian Guidelines) with or without decongestive lymphatic therapy performed by a professional who has received training and certification in the technique of lymphatic draining massage.
Duration: One year after the last patient is randomized.
Conditions
- Breast Cancer
- Lymphedema
Interventions
- PROCEDURE
-
Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)
20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove
Sponsors & Collaborators
-
Canadian Breast Cancer Research Alliance
collaborator OTHER -
Ontario Clinical Oncology Group (OCOG)
lead OTHER
Principal Investigators
-
Ian Dayes, MD · Ontario Clinical Oncology Group (OCOG)
-
Tim Whelan, MD · McMaster University
-
Jim Julian, M. Math · McMaster University
-
Lyn Kligman, RN · London Regional Cancer Centre
-
Kathy Pritchard, MD · Sunnybrook Regional Cancer Centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
- Primary Completion
- 2009-02-28
- Completion
- 2010-02-28
Countries
- Canada
Study Locations
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