Breast Cancer Clinical Trial
Official title:
Effect of Physical Therapy on Breast Cancer Related Lymphedema; A Multicenter, Randomized, Single-blind, Equivalence Trial
Verified date | January 2023 |
Source | Hospital of South West Jutland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 1, 2017 |
Est. primary completion date | September 1, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Hospital of Southwest Denmark | Esbjerg | Region Of Southern Denmark |
Denmark | Department of Rehabilitation, Odense University Hospital | Odense | Region Of Southern Denmark |
Denmark | Department of Physical Therapy, Lillebaelt Hospital | Vejle | Region Of Southern Denmark |
Lead Sponsor | Collaborator |
---|---|
Hospital of South West Jutland |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage volume reduction of lymphedema (%) from baseline to week 4. Percentage volume reduction of lymphedema (%) from week 4 to week 7 | 7 months | ||
Primary | The percentage volume reduction of lymphoedema (%) | 7 months | ||
Secondary | 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 |
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