Effect of Physical Therapy on Breast Cancer Related Lymphedema

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.

Full Title of Study: “Effect of Physical Therapy on Breast Cancer Related Lymphedema; A Multicenter, Randomized, Single-blind, Equivalence Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2017

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

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Physical TherapyB
    • Group B
  • Placebo Comparator: Physical TherapyA
    • Group A

Clinical Trial Outcome Measures

Primary Measures

  • The percentage volume reduction of lymphoedema (%)
    • Time Frame: 7 months

Secondary Measures

  • Differences in circumference of the arm (composite outcome measure), bodyweight, patient sensation of heaviness, patient sensation of tension, and quality of life
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital of South West Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bibi Gram, Associate Professor, PhD – Hospital of South West Jutland
  • Overall Official(s)
    • Bibi Gram, PhD, Study Director, THe Hospital of Southwest Denmark

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