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

This study has been completed.
Sponsor:
Collaborator:
Canadian Breast Cancer Research Alliance
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00201890
First received: September 12, 2005
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Breast Cancer
Lymphedema
Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • Percent reduction in excess arm volume as calculated from circumferential arm measurements [ Time Frame: at 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of arm function [ Time Frame: Midtreatment,6,12 24,52 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Midtreament, 6 12,24,52 weeks ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: March 2003
Study Completion Date: February 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201890

Locations
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
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
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00201890     History of Changes
Other Study ID Numbers: CBCRA- 013260
Study First Received: September 12, 2005
Last Updated: October 9, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Breast Cancer
Lymphedema
Treatment
Massage
Randomized
DLT therapy
Quality of Life
Decongestive Therapy
Breast Cancer related Lymphedema

Additional relevant MeSH terms:
Lymphedema
Breast Neoplasms
Lymphatic Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014