Effect of Physical Therapy on Breast Cancer Related Lymphedema; A Multicenter, Randomized, Single-blind, Equivalence Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- The percentage volume reduction of lymphoedema (%)
Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The percentage volume reduction of lymphoedema (%)
Time Frame: 7 months
Secondary Outcomes
- Differences in circumference of the arm (composite outcome measure), bodyweight, patient sensation of heaviness, patient sensation of tension, and quality of life(7 months)
Investigators
Valgerdur Hilmarsdottir Gram
Associate Professor, PhD
Esbjerg Hospital - University Hospital of Southern Denmark