35P - Prospective study assessing the efficacy and safety of a scalp cooling device for the prevention of alopecia in breast cancer patients undergoing (neo)adjuvant chemotherapy

Background

Chemotherapy-induced alopecia is one of the most distressing symptoms for cancer patients undergoing cytotoxic chemotherapy. In this prospective two-center study, the objectives were to determine the efficacy and toxicity of a scalp-cooling device in the prevention of alopecia associated with chemotherapy.

Methods

Breast cancer patients who were planning for (neo)adjuvant chemotherapy consisting of taxane- and/or anthracycline- based regimens, with or without anti-HER2 therapy were invited to participate. They underwent a scalp cooling system offered by the Orbis Paxman Hair Loss Prevention System. The following were measured during the study: extent of hair loss based on Dean score (score ranges 0-4; 0-2 score reflects hair loss of 50% or less) 4 weeks after the completion of all cycles of chemotherapy, as determined by patients and independent assessors. Adverse events (AEs), specifically alopecia and potential study-related AEs, were graded according to NCI CTCAE v4.0.

Results

52 patients were enrolled into the study. 6 patients were excluded due to subjects’ own request (3), abnormal thyroid function (2) and anaemia (1). Of the remaining 46 patients, 50% each had taxane-based and taxane-anthracycline-based regimens. 3 of the 46 patients did not undergo any assessments after enrolment, resulting in 43 being assessable for outcomes. The median age was 51.5 years. A Dean score of 0-2 for hair loss was reported by 30.2% of the patients and 32.6% of the assessors. Only 4 patients (8.7%) did not require wearing headcover during the study. Alopecia grading were: grade 0 (9.3%), grade 1 (23.3%) and grade 2 (67.4%). Potential study-related AEs included dizziness [grade 1 (11.6%); grade 2 (2.3%)], headaches [grade 1 (4.7%)], complaint of cooling [grade 1 92.3%)]; there were no grade 3 or above toxicities.

Conclusions

In contrast to previous reports, the current scalp cooling system provided a lower efficacy in preventing alopecia in breast cancer patients also undergoing chemotherapy.

Acknowledgement: The scalp cooling system was provided by Orbis Paxman Hair Loss Prevention System.

Clinical trial identification

NCT4630080.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.