IRB Study Number 21-183
Status Recruiting
Location Cleveland Clinic Main Campus
Institutes Digestive Disease & Surgery Institute, Taussig Cancer Institute
Description
The primary objective of this study is to determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no ARM) versus Group II (Arm).
The secondary objectives of this study are 1) to compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A); 2) To evaluate the technical success of performance of ARM procedure (identification of ARM lymphatics and the ability to space or reapproximate ARM lymphatics; and 3) To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM.
The exploratory objective is to assess the occurrence of lymphedema as a function of radiotherapy use and targets.
Inclusion Criteria
- Documentation of Disease: cT1-3 patients undergoing axillary surgery who additionally meet one of the following conditions:
a. Clinically node negative patients undergoing mastectomy and SLNB with possible ALND if SLNB is positive. If ALND is performed during a separate operation, ARM procedure must be repeated. Clinically node negative is defined by i) negative clinical exam and/or ii) negative axillary US and/or iii) negative needle biopsy of sonographically suspicious axillary nodes as applicable to each case.
b. Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery.
Prior Treatment: No prior axillary surgery on the ipsilateral side except needle biopsy or concurrent SLNB. (** Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration.)
No prior history of ipsilateral breast cancer (invasive or DCIS). LCIS and benign disease are allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks before registration).
No bilateral invasive breast cancer
No matted nodes (by clinical exam)
No history of lymphedema of either arm
No known allergies blue dyes, including make-up containing blue dye
In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English.
Female
Age ≥ 18 years
ECOG Performance Status 0, 1 or 2.
Required initial Laboratory Values: Creatinine: ≤ 1.5 x upper limit of normal (ULN
Exclusion Criteria
If any of the inclusion criteria cannot be met.
