Lymphedema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria: Bilateral lymphedema. Breast cancer recurrence. Active clinical infection. Deep venous thrombosis. Pre-existent lymphedema.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be percentage reduction in the excess limb volume. The normal limb acts as the patient*s own control. Inverse water volumetry (gold standard for measuring limb volume) will be used to quantify limb volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| Health care costs will be measured and evaluated. For this we refer to the HTA-methodology study. The quality of life will be measured by means of two validated instruments at the time of enrolment, after completing the treatment, and at 6 months after inclusion: functional assessment of cancer therapy (FACTB) with the FACTB Plus 4 subscale, and the EuroQol-50. | — |
Countries
Netherlands