Status:
COMPLETED
Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY"
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Canadian Breast Cancer Research Alliance
Conditions:
Breast Cancer
Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ...
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 afte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00201890
Start Date
March 1 2003
End Date
February 1 2010
Last Update
October 10 2012
Active Locations (9)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2
2
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
3
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
4
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6