Effect of Physical Therapy on Breast Cancer Related Lymphedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-09-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Lymphoedema Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physical TherapyB

Group B

Group Type ACTIVE_COMPARATOR

Physical TherapyA

Intervention Type PROCEDURE

Group A:

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

Physical TherapyA

Group A

Group Type PLACEBO_COMPARATOR

Physical TherapyB

Intervention Type PROCEDURE

Group B:

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

Interventions

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Physical TherapyA

Group A:

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

Intervention Type PROCEDURE

Physical TherapyB

Group B:

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No