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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer, Lymphedema

Intervention / Treatment
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* Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy) | Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)<br>* 20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove<br>* Other names: Elastic Compression Sleeeve and Glove (Arm 2);|
| No Intervention: 2<br>Standard of Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in excess arm volume as calculated from circumferential arm measurements |  | at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of arm function |  | Midtreatment,6,12 24,52 weeks | 
| Quality of life |  | Midtreament, 6 12,24,52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Lymphedema, Treatment, Massage, Randomized, DLT therapy, Quality of Life, Decongestive Therapy, Breast Cancer related Lymphedema