Feasibility of a Keratin-Based Topical Cream for Radiation Dermatitis in Patients with Head and Neck Cancer: Results of a Randomized Pilot Study

Abstract

Acute radiation dermatitis (RD) is a frequent toxicity associated with radiotherapy (RT) for head and neck cancer (HNC). KeraStat Cream (KC), an emulsion-based wound dressing that acts as a protective barrier that promotes the healing of minor skin wounds and partial-thickness burns, has not yet been studied in patients receiving RT for HNC. This randomized, open-label pilot study enrolled patients with HNC planned to receive definitive or postoperative RT to a total dose of at least 60 Gy. The study excluded patients with a history of prior RT, use of topical corticosteroids, scleroderma, lupus, or treatment with anti-EGFR therapy. Eligible patients were randomized to KC or routine skin care (RSC, patient choice of a variety of commercially available topical creams/lotions), applied at least twice daily during and for 1 month after RT. Assessments were performed at baseline, weekly during RT, and 1-month after RT. The primary outcome was adherence to the prescribed skin care regimen (at least 10 applications per week of treatment, starting at week 2). Secondary outcomes were the incidence rates of clinician-rated and patient-reported dermatitis (CTCAE and PRO-CTCAE grades 2+) and the Dermatologic Life Quality Index (DLQI, range 0-30 with a higher number indicating worse skin-related quality of life) at the last assessment before radiotherapy completion (end-RT). Of 29 patients enrolled, 24 (n = 12 in each group) were randomized and completed the study. Most patients had stage III-IV disease (17, 71%), and the most common primary site was the oropharynx (n = 11, 46%), followed by the oral cavity (n = 7), larynx (n = 5), and sinonasal (n = 1). The median RT dose was 68 Gy (range 60-70), median skin V60 was 37.2 cc (range 1.5-107.6), and median skin V70 was 0 cc (range 0-24.9), with no differences between groups. The bilateral neck was treated in most patients (n = 19, 79%), primary site treated in 3 and unilateral neck treated in 2 patients. Most patients received concurrent chemotherapy (n = 18, 75%). Complete adherence to assigned skin care was observed in 7/12 (58%) patients in the RSC group vs. 10/12 (83%) patients in the KC group (p = 0.65). Nearly all patient-weeks were adherent: 64/67 patients in the KC group and 61/68 patients in the RSC group (p = 0.20). Incidence rates of G2+ RD were similar between the KC and RSC groups: CTCAE, 9/12 vs. 7/12 (p = 0.67); PRO-CTCAE, 10/12 vs. 8/12 (p = 0.64). When measured at end-RT, mean RD scores were similar between the KC and RSC groups: CTCAE, 1.4 vs. 1.8 (p = 0.30); PRO-CTCAE, 2.0 vs. 2.0 (p = 1); DLQI (4.8 vs. 4.6, p = 0.92). Repeated measures analysis showed no difference between arms for CTCAE (p = 0.72), PRO-CTCAE (p = 0.96), or DLQI (p = 0.78). A randomized study of KC vs. RSC is feasible with good adherence to assigned skin care, particularly in the KC group. Future randomized trials are warranted to investigate the efficacy of this novel topical approach to RD during radiotherapy for HNC.