A Phase 3 interventional study of Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1) in Breast Cancer and Lymphedema, sponsored by Ontario Clinical Oncology Group (OCOG). Completed at 9 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-10.
Sponsored by Ontario Clinical Oncology Group (OCOG) · Phase 3, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 103 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Ontario Clinical Oncology Group (OCOG) is the lead sponsor of 56 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy)
Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)
Standard of Care
20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove
Also known as: Elastic Compression Sleeeve and Glove (Arm 2)
Percent reduction in excess arm volume as calculated from circumferential arm measurements
Time frame: at 6 weeks
Measurement of arm function
Time frame: Midtreatment,6,12 24,52 weeks
Quality of life
Time frame: Midtreament, 6 12,24,52 weeks
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Ontario Clinical Oncology Group (OCOG)