Effect of Physical Therapy on Breast Cancer Related Lymphedema

Not Applicable

Completed

• Conditions: Breast Cancer; Lymphoedema
• Interventions: Procedure: Physical TherapyA; Procedure: Physical TherapyB

• Registration Number: NCT02015897
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

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 Timeline

• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Study Start: 2014-01
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical TherapyB	Physical TherapyA	Group B
Physical TherapyA	Physical TherapyB	Group A

Primary Outcome Measures

Name	Time	Method
The percentage volume reduction of lymphoedema (%)	7 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

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, Denmark