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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201890
• Other study ID #: CBCRA- 013260
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 9, 2012
• Start date: March 2003
• Est. completion date: February 2010

Study information

• Verified date: October 2012
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Centre	London	Ontario
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	Thunder Bay Regional Health Science Centre, Regional Cancer Centre	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Sunnybrook Regional Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Canadian Breast Cancer Research Alliance

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in excess arm volume as calculated from circumferential arm measurements		at 6 weeks	Yes
Secondary	Measurement of arm function		Midtreatment,6,12 24,52 weeks	No
Secondary	Quality of life		Midtreament, 6 12,24,52 weeks	No