Effect of Physical Therapy on Breast Cancer Related Lymphedema

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymphoedema
• Intervention / Treatment: Procedure: Physical TherapyA; Procedure: Physical TherapyB

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Esbjerg, Region Of Southern Denmark, Denmark, 6700
      • Hospital of Southwest Denmark
    • Odense, Region Of Southern Denmark, Denmark, 5000
      • Department of Rehabilitation, Odense University Hospital
    • Vejle, Region Of Southern Denmark, Denmark, 7000
      • Department of Physical Therapy, Lillebaelt Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Physical TherapyB; Group B	Procedure: Physical TherapyA; Group A: Skin care; Manual lymphatic drainage; Bandaging using Coban™2Lite; Guidance on physical activity
PLACEBO_COMPARATOR: Physical TherapyA; Group A	Procedure: Physical TherapyB; Group B: Skin care; Bandaging using Coban™2Lite; Guidance on physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage volume reduction of lymphoedema (%)	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 months

Other Outcome Measures

Outcome Measure	Time Frame
Percentage volume reduction of lymphedema (%) from baseline to week 4. Percentage volume reduction of lymphedema (%) from week 4 to week 7	7 months

Collaborators and Investigators

• Sponsor: Hospital of South West Jutland
• Investigators: Study Director: Bibi Gram, PhD, THe Hospital of Southwest Denmark

Publications and helpful links

General Publications

• Tambour M, Holt M, Speyer A, Christensen R, Gram B. Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial. Br J Cancer. 2018 Nov;119(10):1215-1222. doi: 10.1038/s41416-018-0306-4. Epub 2018 Oct 24.
• Tambour M, Tange B, Christensen R, Gram B. Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial. BMC Cancer. 2014 Apr 3;14:239. doi: 10.1186/1471-2407-14-239.

Helpful Links

• Link to the Hospital of Southwest Denmark

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (ESTIMATE): December 19, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: S-20130091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO