Reduction of breast lymphoedema symptoms secondary to breast cancer: Phase I/II randomised controlled trial

Not Applicable

Recruiting

• Conditions: Breast swelling secondary to treatment of breast cancer; Physical Medicine / Rehabilitation - Physiotherapy; Cancer - Breast; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12612000771853
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 103

Inclusion Criteria

Stage I-III breast cancer and treated with wide local excision and axillary surgery for their breast cancer; have developed unilateral breast lymphoedema ; have had stable lymphoedema for at least 3 months; and
are sedentary.

Exclusion Criteria

Have had surgery for their breast cancer within the last 3 months; currently having active treatment for cancer; have a history of bilateral lymph node dissection; have a history of primary lymphoedema ; have had intensive therapy for their lymphoedema within the last 3 months; have had an infection requiring antibiotic treatment in the lymphoedematous region within the last 3 months; are unable to elevate their upper limbs by > 120 degrees minimum; have musculoskeletal or neurological conditions that would affect exercise training and/or assessments; and have any medical conditions (including surgeries) that could prevent participation in exercise.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ymphoedema status: Bioimpedance spectroscopy[Baseline, 3 months];Breast ultrasound measurements[Baseline, 3 months];Breast Volume measurements derived from measures taken with a tape measure (Kovacs et al, Breast. 2007 16(2):137-45.[Baseline, 3 months]

Secondary Outcome Measures

Name	Time	Method
ymphoedema Symptom Intensity and Distress Survey-Arm and Trunk (LSIDS-AT)[Baseline, 3 months];European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3 (QLQ-C30) and Breast module (BR23)[Baseline, 3 months];Maximal upper and lower limb muscle strength will be assessed with by a 1-RM test using an isokinetic dynamometer.[Baseline, 3 months];YMCA cycle ergotemtry test[Baseline, 3 months]