Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.
Cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. The investigators are hoping that using the PAXMAN Orbis Scalp Cooling Device may stop patients who are undergoing chemotherapy from losing their hair.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
236
Treatment with Orbis scalp cooling cap
No treatment to prevent hair loss
Hematology & Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Hair Preservation
The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade \<2, and will be assessed by a healthcare professional who is blinded to study treatment.
Time frame: 4 to 8 Months
Time to First Recurrence and Overall Survival
A safety follow-up for safety data will be done yearly for 5 years looking at time to first recurrence of breast cancer, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. This will be collected during routine clinical observation
Time frame: 5 years
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Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
USOncology / Texas Oncology-Memorial City
Houston, Texas, United States
Lester and Sue Smith Breast Center at Baylor College of Medicine
Houston, Texas, United States