Complete Decongestive Therapy in Breast Cancer-Related Lymphedema

Study Overview
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Brief Summary
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The purpose of this study is to investigate which number of lymphedema therapy treatments/week best reduces upper extremity swelling, increased arm function, and reduces the most lymphedema symptoms.

Detailed Description
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Complete Decongestive Therapy (CDT) is the gold standard in lymphedema care and has been found to be efficacious in numerous studies. These studies have varying treatment protocols of intensive phase I CDT with dosing ranging from 2x/wk for a mean of 7.5 wks to 6x/wk until a plateau in arm volumes were achieved. This variability in research does not lend itself to recommendations of evidence-based protocol use of CDT in an outpatient setting. Although CDT is backed by efficacy studies, the daily dosing given to patients is based on anecdotal rather than evidence-based practice. Because the traditional protocol was developed from longstanding experience, research is necessary to determine the best dosing of the intensive phase of CDT. The purpose of this study is to investigate what level of dosing in the intensive CDT phase promotes best volume reduction and increased upper extremity function in the breast cancer-related lymphedema patient population. This particular study will answer: What dosing produces best volumetric reduction and upper extremity function in the intensive phase of complete decongestive therapy for outpatients with breast cancer-related lymphedema 2x/wk for 4wks or 4x/wk for 4 wks?

Official Title
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Therapeutic Quantity of Complete Decongestive Therapy in Breast Cancer-Related Lymphedema: A Double Blinded Randomized Control Trial

Conditions
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Lymphedema of Upper Limb

Intervention / Treatment
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* Other: Standard of care complete decongestive therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have active unilateral breast cancer-related lymphedema Medically stable Have not participated in lymphedema therapy the past 3 months An affected limb volume measurement of >10% excess volume Ages 18-95 years old Patients undergoing any medical treatment for their breast cancer diagnosis will be included in this study. Patients with any stage breast cancer will be included in this study. Patients with a prior diagnosis of breast cancer, other cancer will be included in this study. There is no minimum time requirement that has prolapsed between their diagnosis and this study. All subjects must have given signed, informed consent prior to registration on study. Exclusion Criteria: Prophylactic treatment indicated A presence of upper extremity wounds present Active signs of infection or deep vein thrombosis (DVT) Bilateral lymphedema present Evidence of contraindications to CDT: uncontrolled hypertension, heart disease including congestive heart failure, and renal insufficiency Severe lymphedema present as defined by > 30% increase in limb volume

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 2x/wk<br>Participants will receive standard of care complete decongestive therapy 2x/wk for 4 weeks. | Other: Standard of care complete decongestive therapy<br>* Participants will receive standard of care complete decongestive therapy consisting of meticulous skin and nail care, manual lymphatic drainage, compression bandaging, remedial exercises and self-care training.<br>|
| Experimental: Treatment 4x/wk<br>Participants will receive standard of care complete decongestive therapy 4x/wk for 4 weeks. | Other: Standard of care complete decongestive therapy<br>* Participants will receive standard of care complete decongestive therapy consisting of meticulous skin and nail care, manual lymphatic drainage, compression bandaging, remedial exercises and self-care training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in impairments in function, activity limitations, and participation restrictions | A questionnaire looking at impairments in function, activity limitations, and participation restrictions consists of 29 questions divided into five domains: physical function, mental function, household activities, mobility activities, and life and social activities. | At first treatment appointment (roughly week 1), after 4 weeks of treatment, at discharge (roughly after 8 weeks), and at a 4 week follow-up session after discharge (up to 12 weeks) | 
| Changes from baseline in symptoms associated with lymphedema | This outcome measure will assess the presence of symptoms associated with lymphedema. | At first treatment appointment (week 1), after 4 weeks of treatment, at discharge (roughly after 8 weeks), and at a 4 week follow-up session after discharge (up to 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in lymphedema volume | Circumferential measurements by tape measure calculated into volume percentage | At first treatment appointment (week 1), after 4 weeks of treatment, at discharge (roughly after 8 weeks), and at a 4 week follow-up session after discharge (up to 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Lymphedema