Effect of Physical Therapy on Breast Cancer Related Lymphedema

Study Overview
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Brief Summary
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The objective of this study is to investigate if Complete Decongestive Therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer.

Detailed Description
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Physical therapy treatment of patients with lymphoedema includes treatment based on the principles of 'Complete Decongestive Therapy' (CDT). CDT consists of following components; skin care, manual lymphatic drainage, bandaging and exercises. Regarding what type of treatment of treatments is most effective, the scientific evidence is sparse. Studies have focused on the time-consuming manual lymphatic drainage, but the scientific evidence is not consistent. A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with lymphoedema will be recruited from 3 hospitals and randomised into one of two treatment groups: A: Complete Decongestive TherapyA (incl. manual drainage) or B: Complete Decongestive TherapyB (except manual lymphatic drainage

Official Title
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Effect of Physical Therapy on Breast Cancer Related Lymphedema; A Multicenter, Randomized, Single-blind, Equivalence Trial

Conditions
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Lymphoedema, Breast Cancer

Intervention / Treatment
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* Procedure: Physical TherapyA
* Procedure: Physical TherapyB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnose breast cancer regardless of date for operation and identified lymphoedema Precede ultrasonic scanning of axilla in order to exclude local relapse Lymphoedema > 2 cm i.e. stage II-III Completed radiotherapy and/or chemotherapy at least 2 months prior inclusion Exclusion Criteria: Relapse of breast cancer Untreated infection Untreated heart failure Untreated renal failure Untreated deep venous thrombosis in the arm Unable to participate in physiotherapy treatment and/or not able to understand instructions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical TherapyB<br>Group B | Procedure: Physical TherapyA<br>* Group A: Skin care Manual lymphatic drainage Bandaging using Coban™2Lite Guidance on physical activity<br>|
| Placebo Comparator: Physical TherapyA<br>Group A | Procedure: Physical TherapyB<br>* Group B: Skin care Bandaging using Coban™2Lite Guidance on physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage volume reduction of lymphoedema (%) |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in circumference of the arm (composite outcome measure), bodyweight, patient sensation of heaviness, patient sensation of tension, and quality of life | Circumference of the arm consists of 7 measurements but these will be converted to one outcome measure when estimating the difference between baseline and post intervention measurements | 7 months |