INNV-01. PROTECT STUDY: PROPHYLACTIC SKIN TOXICITY THERAPY WITH CLINDAMYCIN AND CLOBETASOL OR SKIN BARRIER IN GLIOBLASTOMA PATIENTS TREATED WITH TUMOR TREATING FIELDS

Abstract

BACKGROUND: Tumor treating fields (TTFields) are non‐invasive, antimitotic low intensity, intermediate frequency (200 kHz) alternating electric fields. TTFields have demonstrated survival advantage when combined with maintenance TMZ in newly diagnosed glioblastoma. TTFields are applied continuously (>18 hours/day) using a set of four transducer arrays placed on the patients scalp. The main TTFields‐related adverse event is mild‐moderate dermatitis and pruritus. Strategies that mitigate skin events may improve quality of life, adherence, and prevent treatment interruptions. Several clinical trials are evaluating the concomitant use of TTFields with a variety of immunotherapies which are also associated with dermatologic toxicities. This multicenter, prospective, randomized, double‐blind pilot study will test the efficacy and safety of topical clobetasol and clindamycin and a skin barrier to prevent skin events from TTFields. METHODS: Patients (n=90) will be randomized to receive either: clobetasol propionate, and clindamycin (n=30), topical skin barrier (n=30), or 70% ethanol (n=30, as control group). The primary study outcome is the difference in grade 2 device‐related skin toxicity between the arms at study completion (day 90 '} 14 days). The subjects will be assessed (clinical, QoL, interventions) on day 0, 30, 60, at the end of study day 90, grading will be conducted by CTCAE v5.0 and blinded photograph evaluation. A sample size of 90 patients will allow 80% power to detect a 30% difference in grade 2 dermatitis between the treated and non‐treated sides with a two‐side alpha type I error rate of 5%. Estimated time of accrual is 36 months with an accrual rate of 2‐3 patients per month. Anticipated time to complete the study is 39 months.