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NCT Number: NCT02015897

Effect of Physical Therapy on Breast Cancer Related Lymphedema

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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Key information

Conditions

Lymphoedema Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Southwest Denmark, Esbjerg, Region Syddanmark, Denmark

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical TherapyA

Procedure

Group A:

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

Physical TherapyB

Procedure

Group B:

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

Primary outcomes

  1. The percentage volume reduction of lymphoedema (%)

    Time frame: 7 months

Secondary outcomes

  1. 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

Other outcomes

  1. Percentage volume reduction of lymphedema (%) from baseline to week 4. Percentage volume reduction of lymphedema (%) from week 4 to week 7

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Registry information

Official study title

Effect of Physical Therapy on Breast Cancer Related Lymphedema; A Multicenter, Randomized, Single-blind, Equivalence Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2013
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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