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

NCT ID: NCT00201890

Last Updated: 2012-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2010-02-28

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.

Conditions

Breast Cancer; Lymphedema

Keywords

Breast Cancer; Lymphedema; Treatment; Massage; Randomized; DLT therapy; Quality of Life; Decongestive Therapy; Breast Cancer related Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy)

Group Type: EXPERIMENTAL

Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)

Intervention Type: PROCEDURE

20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove

2

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Elastic Compression Sleeeve and Glove (Arm 2)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Breast Cancer Research Alliance

OTHER

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Dayes, MD

Role: STUDY_DIRECTOR

Ontario Clinical Oncology Group (OCOG)

Tim Whelan, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Jim Julian, M. Math

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Lyn Kligman, RN

Role: PRINCIPAL_INVESTIGATOR

London Regional Cancer Centre

Kathy Pritchard, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Regional Cancer Centre

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

Countries

Canada

Other Identifiers

CBCRA- 013260

Identifier Type: -

Identifier Source: org_study_id