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Spots Global Cancer Trial Database for Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY"

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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