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Brief Title: Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY"
Official Title: DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer
Study ID: NCT00201890
Brief 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.
Detailed Description: Randomized patients receive either standard of care or standard of care plus DLT (five massage sessions per week for 4 consecutive weeks). Primary evaluation of all patients is recorded six weeks after randomization by measuring the affected limb and comparing with the unaffected one. There is an extended follow-up of one year.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Cross Cancer Institute, Edmonton, Alberta, Canada
Dr. Leon Richard Oncology Centre, Moncton, New Brunswick, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Regional Cancer Centre, London, Ontario, Canada
Thunder Bay Regional Health Science Centre, Regional Cancer Centre, Thunder Bay, Ontario, Canada
Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Name: Ian Dayes, MD
Affiliation: Ontario Clinical Oncology Group (OCOG)
Role: STUDY_DIRECTOR
Name: Tim Whelan, MD
Affiliation: McMaster University
Role: PRINCIPAL_INVESTIGATOR
Name: Jim Julian, M. Math
Affiliation: McMaster University
Role: PRINCIPAL_INVESTIGATOR
Name: Lyn Kligman, RN
Affiliation: London Regional Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Kathy Pritchard, MD
Affiliation: Sunnybrook Regional Cancer Centre
Role: PRINCIPAL_INVESTIGATOR