Effect of Physical Therapy on Breast Cancer Related Lymphedema

Modulex

Status: Completed

Conditions: Breast Cancer; Lymphoedema

Treatments: Procedure: Physical TherapyA; Procedure: Physical TherapyB

Study type: Interventional

Funder types: Other

Identifiers

NCT02015897

S-20130091

Details and patient eligibility

About

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 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

Enrollment: 80 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Physical TherapyB

Active Comparator group

Description:

Group B

Treatment:

Procedure: Physical TherapyA

Physical TherapyA

Placebo Comparator group

Description:

Group A

Treatment:

Procedure: Physical TherapyB