Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.
Stopped early · Phase 2
Conditions studied: Lymphedema, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
In brief
Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer
Key facts
- Study ID
- NCT01276054
- Run by
- University of Southern California
- People needed
- 4
- Starts
- 2010-12-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2014-08-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Stage 0, I, and II Breast Cancer
- Not pregnant or breastfeeding
- Breast cancer or prophylactic mastectomy requiring axillary nodal staging
- Ability to read and/or comprehend consent form and questionnaires
- Ability to follow-up per protocol
- Unilateral axillary staging
You may not qualify if…
- Stage 3
- Previous axillary lymph node dissection
- Neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration
- Allergy to blue dyes or iodine; NOTE: a non-blue dye or non-iodine-containing dye may be used in these patients
- Patients with implanted medical devices such as a pacemaker may undergo perometry, but not BIS (Bioelectrical Impedance Spectroscopy)
- Previous diagnosis of LE (lymphedema) of either extremity
- Bilateral axillary staging
Where it is running
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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