
Paxman Scalp Cooling System Is FDA Approved for Chemotherapy-Associated Alopecia
The approval of the Paxman Scalp Cooling System follows a randomized clinical trial, whose results were published in JAMA following an interim analysis.
The Paxman Scalp Cooling System, which reduces or prevents hair loss associated with chemotherapy treatment in women with breast cancer, is
Chemotherapy-associated alopecia, which drastically changes how a person looks and feels, can significantly impact a patient’s quality of life, over and above the physical exhaustion associated with their treatment. Studies have shown that for some patients, alopecia can rank just below nausea and vomiting as the most distressing side effect of cancer treatment.
Patients currently have access to several
In the
Of the 142 evaluable patients at the time of the interim analysis, half the women who received scalp cooling (48 of 95) had successful hair preservation (95% CI, 40.7%-60.4%), compared with none in the control cohort (95% CI, 0%-7.6%). Fifty-four grade 1 and 2 device-related adverse events were reported.
Scalp-cooling devices are not without challenges. Nancy Marshall, cofounder of The Rapunzel Project,
Another aspect is the cost associated with using the device. FDA approval does not automatically translate into reimbursement by health plans. Digitana
A
Study sites for the Paxman device included Baylor College of Medicine, the Memorial Sloan Kettering Cancer Center, the US Oncology Network, and the MD Anderson Cancer Center.
Newsletter
Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics.