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

DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymphedema
• Intervention / Treatment: Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G1Z2
      • Cross Cancer Institute
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Dr. Leon Richard Oncology Centre
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Dr. H. Bliss Murphy Cancer Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Centre
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Science Centre, Regional Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Regional Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy)	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; Other Names: Elastic Compression Sleeeve and Glove (Arm 2)
No Intervention: 2; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent reduction in excess arm volume as calculated from circumferential arm measurements	at 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of arm function	Midtreatment,6,12 24,52 weeks
Quality of life	Midtreament, 6 12,24,52 weeks

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: Canadian Breast Cancer Research Alliance
• Investigators: Study Director: Ian Dayes, MD, Ontario Clinical Oncology Group (OCOG); Principal Investigator: Tim Whelan, MD, McMaster University; Principal Investigator: Jim Julian, M. Math, McMaster University; Principal Investigator: Lyn Kligman, RN, London Regional Cancer Centre; Principal Investigator: Kathy Pritchard, MD, Sunnybrook Regional Cancer Centre

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): October 10, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Treatment; Lymphedema; Breast Cancer; Quality of Life; Randomized; Massage; DLT therapy; Decongestive Therapy; Breast Cancer related Lymphedema
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: CBCRA- 013260