A Nonrandomized Clinical Trial Investigating Keratinocyte Growth Factor-Hair Serum for the Prevention of Chemotherapy-Induced Alopecia.

[INTRODUCTION] Chemotherapy-induced alopecia (CIA) is known to have a significant psychological and quality of life impact. Although cold caps have been shown to prevent CIA, expense and extension of treatment durations are barriers for routine clinical use. Keratinocyte growth factor (KGF) has been shown to have cytoprotective effects on human hair follicles and reduce alopecia in preclinical models. We hypothesized that KGF-hair serum (KGF-HS) will prevent CIA.

[METHODS] We conducted a Simon two-stage, single-arm clinical study in women with early-stage breast cancer (ESBC) scheduled to receive at least four cycles of chemotherapy. The primary outcome was preservation of hair after chemotherapy, whereas secondary measures included patient-reported wig use, comfort, and validated quality-of-life instruments (EORTC QLQ-C30, HADS, and BIS).

[RESULTS] Twenty patients were evaluable for the primary end point. None achieved meaningful hair preservation. The average duration of treatment of KGF-HS application was 4.6 weeks.

[CONCLUSION] In this study of women with ESBC receiving chemotherapy, using the KGF-HS did not prevent CIA. There was no statistical difference pre- and post-study BIS, HADS, and EORTC-30 scores. Application of the KGF-HS was reported to be easy, with minimal discomfort, and a non-oily appearance. Patients' ease of use and acceptability of a topical agent for CIA further supports the development of new agents for a more practical and affordable alternative to scalp cooling.

[TRIAL REGISTRATION] clinicaltrials.gov: NCT04554732.