Effect of Physical Therapy on Breast Cancer Related Lymphedema

N/ACompletedNCT02015897

Esbjerg Hospital - University Hospital of Southern Denmark80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lymphoedema Breast Cancer

Interventions

Physical TherapyAPROCEDURE

Group A: * Skin care * Manual lymphatic drainage * Bandaging using Coban™2Lite * Guidance on physical activity

Physical TherapyBPROCEDURE

Group B: * Skin care * Bandaging using Coban™2Lite * Guidance on physical activity

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (3)

Hospital of Southwest Denmark

Esbjerg, Region Syddanmark, Denmark

Department of Rehabilitation, Odense University Hospital

Odense, Region Syddanmark, Denmark

Department of Physical Therapy, Lillebaelt Hospital

Vejle, Region Syddanmark, Denmark

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

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

Time frame: 7 months

Data from ClinicalTrials.gov

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