The effectiveness of compression therapy in mild arm lymphedema

Not Applicable

Completed

• Conditions: ymphedema; Circulatory System; Lymphoedema, not elsewhere classified

• Registration Number: ISRCTN51918431
• Lead Sponsor: und University

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35657063/ (added 08/06/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37211678/ (added 22/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-31
• Study Start: 2021-09-20
• Last Update Posted: 5 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

1. Women treated for unilateral breast cancer
2. Axillary node dissection
3. Diagnosed with mild arm lymphedema

Exclusion Criteria

1. Recurrent breast cancer
2. Concurrent diseases that could interfere with the measurement of lymphedema
3. Cognitive disability
4. Language difficulties making it hard to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The number (proportion) of women with mild breast cancer-related lymphedema BCRL (defined as Lymphedema Relative Volume [LRV] <8%) exceeding LRV >2% from start or anytime exceeding LRV >10%, measured by the water displacement method (WDM) at baseline and after 1, 2, 3 and 6 months<br> 2. Health-related quality of life (HRQL) measured using the Lymphedema Quality of Life Inventory (LyQLI) at 6 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Arm volume measured by the water displacement method (WDM), local tissue water by Tissue Dielectric Constant (TDC) and subjective symptoms of pain, tension, and heaviness by Visual Analogue Scale (VAS) at baseline and 1, 2, 3, and 6 months<br> 2. Background data including surgical methods and adjuvant treatments collected from medical records and a study-specific questionnaire at baseline<br> 3. Frequency of self-rated physical activity level/exercise and housework collected from a study-specific questionnaire at baseline and at 6 months<br> 4. Frequency of use of compression and performance of simple lymphatic drainage collected from a study-specific questionnaire at 6 months<br>