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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201890 on ClinicalTrials.gov