Breast Cancer, Lymphoedema
Conditions
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
Interventions
PROCEDUREPhysical TherapyA
Group A: * Skin care * Manual lymphatic drainage * Bandaging using Coban™2Lite * Guidance on physical activity
PROCEDUREPhysical TherapyB
Group B: * Skin care * Bandaging using Coban™2Lite * Guidance on physical activity
Sponsors
Esbjerg Hospital - University Hospital of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage volume reduction of lymphoedema (%) | 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in circumference of the arm (composite outcome measure), bodyweight, patient sensation of heaviness, patient sensation of tension, and quality of life | 7 months | 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 |
Other
| Measure | Time frame |
|---|---|
| Percentage volume reduction of lymphedema (%) from baseline to week 4. Percentage volume reduction of lymphedema (%) from week 4 to week 7 | 7 months |
Countries
Denmark
Outcome results
None listed