Effect of Physical Therapy on Breast Cancer Related Lymphedema

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015897
• Other study ID #: S-20130091
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: September 1, 2017

Study information

• Verified date: January 2023
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphoedema

Intervention

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

Locations

Country	Name	City	State
Denmark	Hospital of Southwest Denmark	Esbjerg	Region Of Southern Denmark
Denmark	Department of Rehabilitation, Odense University Hospital	Odense	Region Of Southern Denmark
Denmark	Department of Physical Therapy, Lillebaelt Hospital	Vejle	Region Of Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Hospital of South West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage volume reduction of lymphedema (%) from baseline to week 4. Percentage volume reduction of lymphedema (%) from week 4 to week 7		7 months
Primary	The percentage volume reduction of lymphoedema (%)		7 months
Secondary	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

External Links

•   Link to the Hospital of Southwest Denmark