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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02015897
Other study ID # S-20130091
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date September 1, 2017

Study information

Verified date January 2023
Source Hospital of South West Jutland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Physical TherapyA
Group A: Skin care Manual lymphatic drainage Bandaging using Coban™2Lite Guidance on physical activity
Physical TherapyB
Group B: Skin care Bandaging using Coban™2Lite Guidance on physical activity

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hospital of South West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

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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