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

Phase 3

Completed

• Conditions: Lymphedema; Breast Cancer
• Interventions: Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)

• Registration Number: NCT00201890
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2009-02
• Study Completion: 2010-02
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-09
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

Inclusion Criteria

• Women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 15% increase in arm volume over the opposite arm.
• Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. This is to ensure that scheduling difficulties with daily treatments do not arise. Patients may be currently taking tamoxifen or similar hormonal treatment.

Exclusion Criteria

• Clinical or radiological evidence of active disease, either local or metastatic.
• History of contralateral cancer, axillary surgery, radiation or bilateral arm edema. (Edema volume will be taken as the increase in volume compared to the unaffected arm; previous therapy in the opposite arm will reduce the accuracy of measuring excess volume related to lymphedema.)
• Previous surgery involving nodal dissection or radiotherapy to other major node-bearing areas in the body such as the mediastinum or pelvis. Disruption of lymphatic flow in these potentially alternate routes may be compromised by such interventions. Patients are eligible after a simple hysterectomy (+/- oophorectomy).
• Previously undergone massage therapy for arm edema, or has used compression sleeve within the last month.
• Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow up.
• Patients for whom massage is contraindicated, such as those with untreated infections or thromboses in the affected arm.
• Unable to commence therapy within 7 days of randomization.
• Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)	Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy)

Primary Outcome Measures

Name	Time	Method
Percent reduction in excess arm volume as calculated from circumferential arm measurements	at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Measurement of arm function	Midtreatment,6,12 24,52 weeks
Quality of life	Midtreament, 6 12,24,52 weeks

Trial Locations

Locations (9)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Dr. Leon Richard Oncology Centre; 🇨🇦 Moncton, New Brunswick, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Thunder Bay Regional Health Science Centre, Regional Cancer Centre; 🇨🇦 Thunder Bay, Ontario, Canada

Sunnybrook Regional Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Dr. H. Bliss Murphy Cancer Centre; 🇨🇦 St. John's, Newfoundland and Labrador, Canada