Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY" - Full Text View

Sponsors and Collaborators:	Ontario Clinical Oncology Group (OCOG) Canadian Breast Cancer Research Alliance
Information provided by:	Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:	NCT00201890

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 III

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Lymphedema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer

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 ]

Estimated Enrollment:	100
Study Start Date:	March 2003
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: No Intervention 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

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

Contacts

Contact: Betsy A MacKinnon, MSc.	905 527 2299 ext 42606	mackinn@mcMaster.ca
Contact: Sharon Nason	905 527 2299 ext 42622

Locations

Canada, Alberta
Cross Cancer Institute	Recruiting
Edmonton, Alberta, Canada, T6G1Z2
Contact: Margie McNeely, PhD 780 432-8716 mmcneely@ualberta.ca
Canada, New Brunswick
Dr. Leon Richard Oncology Centre	Recruiting
Moncton, New Brunswick, Canada, E1C 8X3
Contact: Linda LeBlanc, MD
Contact: Joanne LeBlanc-Chiasson 506 862 4263
Principal Investigator: Linda LeBlanc, MD
Sub-Investigator: Andree Lirette, MD
Sub-Investigator: Fernando Rojas, MD
Saint John Regional Hospital	Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Margot Burnell, MD
Contact: Sharon Turnell
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre	Terminated
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Thunder Bay Regional Health Science Centre, Regional Cancer Centre	Terminated
Thunder Bay, Ontario, Canada, P7B 6V4
London Regional Cancer Centre	Recruiting
London, Ontario, Canada, N6A 4L6
Contact: David P D'Souza, MD 519 685 8650
Principal Investigator: David P D'Souza, MD
Sub-Investigator: Lyn Kligman, MD
Sub-Investigator: Barbara Osinga, RMT
Sunnybrook Regional Cancer Centre	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Kathleen Pritchard, MD 416 480 4616
Principal Investigator: Kathleen Pritchard, MD
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Lee Manchul, MD 416 946 2127
Principal Investigator: Lee Manchul, MD
Juravinski Cancer Centre	Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Ian Dayes, MD 905 387 9495 ext 64704 ian.dayes@hrcc.on.ca
Contact: Jennifer Wiernikowski, MD 905 387 9495 ext 64148
Principal Investigator: Ian Dayes, MD
Sub-Investigator: Tim Whelan, MD
Sub-Investigator: Jennifer Wiernikowski, RN
Sub-Investigator: Donna Lue Reise, RN

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

Canadian Breast Cancer Research Alliance

Investigators

Study Director:	Ian Dayes, MD	Ontario Clinical Oncology Group
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

Responsible Party:	Ontario Clinical Oncology Group ( Dr. Mark Levine/Director OCOG )
Study ID Numbers:	CBCRA- 013260
Study First Received:	September 12, 2005
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00201890
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

Study placed in the following topic categories:

Lymphedema
Lymphatic Diseases
Skin Diseases

Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009