Treatment of breast cancer-associated lymphedema. A randomized study of the (cost-)effectiveness of manual lymphatic drainage and/or intermittent pneumatic compressio
Completed
- Conditions
- Lymphedema100062911004079510025231
- Registration Number
- NL-OMON30736
- Lead Sponsor
- Academisch Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 207
Inclusion Criteria
Untreated lymphedema in one arm, developed after treatment for breast cancer.
An increase in the volume of the affected arm >= 20% compared with the non-affected arm.
Lymphedema developed >= 12 weeks after surgical treatment for breast cancer (axillary lymph node dissection and/or axillary radiation included).
Exclusion Criteria
Bilateral lymphedema.
Breast cancer recurrence.
Active clinical infection.
Deep venous thrombosis.
Pre-existent lymphedema.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure will be percentage reduction in the excess limb<br /><br>volume. The normal limb acts as the patient*s own control. Inverse water<br /><br>volumetry (gold standard for measuring limb volume) will be used to quantify<br /><br>limb volume. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Health care costs will be measured and evaluated. For this we refer to the<br /><br>HTA-methodology study. The quality of life will be measured by means of two<br /><br>validated instruments at the time of enrolment, after completing the treatment,<br /><br>and at 6 months after inclusion: functional assessment of cancer therapy<br /><br>(FACTB) with the FACTB Plus 4 subscale, and the EuroQol-50.</p><br>