COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201890
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 10, 2012
Canadian Breast Cancer Research Alliance
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1) Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer
Study Start Date : March 2003
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

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 Name: Elastic Compression Sleeeve and Glove (Arm 2)

No Intervention: 2
Standard of Care

Primary Outcome Measures :
  1. Percent reduction in excess arm volume as calculated from circumferential arm measurements [ Time Frame: at 6 weeks ]

Secondary Outcome Measures :
  1. Measurement of arm function [ Time Frame: Midtreatment,6,12 24,52 weeks ]
  2. Quality of life [ Time Frame: Midtreament, 6 12,24,52 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201890

Layout table for location information
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2
Canada, New Brunswick
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Thunder Bay Regional Health Science Centre, Regional Cancer Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Breast Cancer Research Alliance
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Ontario Clinical Oncology Group (OCOG) Identifier: NCT00201890    
Other Study ID Numbers: CBCRA- 013260
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by Ontario Clinical Oncology Group (OCOG):
Breast Cancer
DLT therapy
Quality of Life
Decongestive Therapy
Breast Cancer related Lymphedema
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases