Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY"
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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 |
- Percent reduction in excess arm volume as calculated from circumferential arm measurements [ Time Frame: at 6 weeks ] [ Designated as safety issue: Yes ]
- 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 |
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| 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 | |
| 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:
|
Breast Neoplasms Lymphedema Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013