lymfedema swelling
Conditions
Interventions
ALND with or without sparing of the arm lymphatics and arm nodes.
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female mental competent patients of at least 18 years of age with the diagnosis invasive breast cancer with an indication for a complementary axillary lymph node dissection (ALND) based on a positive sentinel lymph node (SLN) are eligible for an ALND-ARM procedure. The indication for a complementary ALND will be made in a multidisciplinary team including an oncologic surgeon, medical oncologist, pathologist, radiologist and a radiotherapist.
Exclusion criteria
Exclusion criteria: Exclusion criteria are: primary ALND based on a clinical positive axilla (proven by cytological punction), a contra-indication for sentinel lymph node biopsy (SLNB), a history of breast-cancer, adverse event during the previous SLNB, pregnancy. Patients excluded for randomization between ALND and ALND-ARM will be possible candidates for the side study in which the feasibility of ARM (without sparing lymphatics and lymph nodes) is investigated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Randomisation study: Complications will be measured after 6, 12 and 24 months after the primary procedure by a nurse practitioner/clinical investigator. The primary end-points of the study are the presence of physical complains consisting of lymphoedema, pain, numbness, loss of shoulder mobility. Primary endpoints: - Breast cancer related lymphoedema (BCRL) - Paraesthesia/numbness - Pain - Loss of arm and shoulder mobility Secundary endpoints: - Quality of live - Axillary recurrende rate Feasibility (side-study): - identification of ARM-nodes - Involvement of the ARM-nodes in the metastatic proces | — |
Secondary
| Measure | Time frame |
|---|---|
| Randomisation study: Secondary endpoints: - Quality of life (QOL) - Axillary recurrence rate Disease free survival during the first 5-10 years will be documented during the routinely control at the outpatient clinic. Feasibility (side-study): n.a. | — |
Countries
Netherlands
Outcome results
None listed