Keratin-based Topical Cream for Radiation Dermatitis During Head and Neck Radiotherapy: a Randomised, Open-label Pilot Study

Overview

Journal J Radiother Pract

Publisher Cambridge University Press

Specialty Radiology

Date 2024 Oct 4

PMID 39363952

Authors

Ryan T Hughes

Beverly J Levine

Bart A Frizzell

Kathryn M Greven

Mercedes Porosnicu

Thomas W Lycan Jr

Luke R Burnett

Karen M Winkfield

Affiliations

Soon will be listed here.

Abstract

Introduction: Radiation dermatitis (RD) is a frequent toxicity during radiotherapy (RT) for head and neck cancer (HNC). We report the first use of KeraStat Cream (KC), a topical, keratin-based wound dressing, in patients with HNC receiving RT.

Methods: This pilot study randomized HNC patients treated with definitive or postoperative RT (≥60 Gy) to KC or standard of care (SOC), applied at least twice daily during and for 1-month after RT. Outcomes of interest included adherence to the assigned regimen (at least 10 applications per week of treatment), clinician- and patient-reported RD, and skin-related quality of life.

Results: 24 patients were randomized and completed the study. Most patients had stage III-IV disease and oropharynx cancer. Median RT dose was 68 Gy; the bilateral neck was treated in 19 patients, and 18 patients received concurrent chemotherapy. Complete adherence was observed in 7/12 (SOC) vs. 10/12 (KC, = 0.65). Adherence by patient-week was 61/68 versus 64/67, respectively ( = 0.20). No differences in RD were observed between groups.

Conclusion: A randomized trial of KC versus SOC in HNC patients treated with RT is feasible with good adherence to study agent. An adequately powered randomized study is warranted to test the efficacy of KC in reducing RD.

References

Jagsi R, Griffith K, Boike T, Walker E, Nurushev T, Grills I . Differences in the Acute Toxic Effects of Breast Radiotherapy by Fractionation Schedule: Comparative Analysis of Physician-Assessed and Patient-Reported Outcomes in a Large Multicenter Cohort. JAMA Oncol. 2015; 1(7):918-30. DOI: 10.1001/jamaoncol.2015.2590. View

Hughes R, Ip E, Urbanic J, Hu J, Weaver K, Lively M . Smoking and Radiation-induced Skin Injury: Analysis of a Multiracial, Multiethnic Prospective Clinical Trial. Clin Breast Cancer. 2022; 22(8):762-770. PMC: 10003823. DOI: 10.1016/j.clbc.2022.09.003. View

Finlay A, Khan G . Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994; 19(3):210-6. DOI: 10.1111/j.1365-2230.1994.tb01167.x. View

Fitzpatrick T . The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988; 124(6):869-71. DOI: 10.1001/archderm.124.6.869. View

Forastiere A, Goepfert H, Maor M, Pajak T, Weber R, Morrison W . Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003; 349(22):2091-8. DOI: 10.1056/NEJMoa031317. View

Neben-Wittich M, Atherton P, Schwartz D, Sloan J, Griffin P, Deming R . Comparison of provider-assessed and patient-reported outcome measures of acute skin toxicity during a Phase III trial of mometasone cream versus placebo during breast radiotherapy: the North Central Cancer Treatment Group (N06C4). Int J Radiat Oncol Biol Phys. 2010; 81(2):397-402. PMC: 3365545. DOI: 10.1016/j.ijrobp.2010.05.065. View

Marcu L, Bezak E . Radiobiological modeling of interplay between accelerated repopulation and altered fractionation schedules in head and neck cancer. J Med Phys. 2010; 34(4):206-11. PMC: 2807142. DOI: 10.4103/0971-6203.56081. View

Yee C, Wang K, Asthana R, Drost L, Lam H, Lee J . Radiation-induced Skin Toxicity in Breast Cancer Patients: A Systematic Review of Randomized Trials. Clin Breast Cancer. 2018; 18(5):e825-e840. DOI: 10.1016/j.clbc.2018.06.015. View

Mannix C, Bartholomay M, Doherty C, Lewis M, Bilodeau M . A feasibility study of low-cost, self-administered skin care interventions in patients with head and neck cancer receiving chemoradiation. Clin J Oncol Nurs. 2012; 16(3):278-85. DOI: 10.1188/12.CJON.278-285. View

10.

Wright J, Takita C, Reis I, Zhao W, Lee E, Nelson O . Prospective evaluation of radiation-induced skin toxicity in a race/ethnically diverse breast cancer population. Cancer Med. 2016; 5(3):454-64. PMC: 4799959. DOI: 10.1002/cam4.608. View

11.

Basra M, Salek M, Camilleri L, Sturkey R, Finlay A . Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015; 230(1):27-33. DOI: 10.1159/000365390. View

12.

Gonzalez Ferreira J, Jaen Olasolo J, Azinovic I, Jeremic B . Effect of radiotherapy delay in overall treatment time on local control and survival in head and neck cancer: Review of the literature. Rep Pract Oncol Radiother. 2015; 20(5):328-39. PMC: 4597087. DOI: 10.1016/j.rpor.2015.05.010. View

13.

Ferreira E, Vasques C, Gadia R, Chan R, Guerra E, Mezzomo L . Topical interventions to prevent acute radiation dermatitis in head and neck cancer patients: a systematic review. Support Care Cancer. 2016; 25(3):1001-1011. DOI: 10.1007/s00520-016-3521-7. View

14.

Schmuth M, Sztankay A, Weinlich G, Linder D, Wimmer M, Fritsch P . Permeability barrier function of skin exposed to ionizing radiation. Arch Dermatol. 2001; 137(8):1019-23. View

15.

Bauer C, Laszewski P, Magnan M . Promoting adherence to skin care practices among patients receiving radiation therapy. Clin J Oncol Nurs. 2015; 19(2):196-203. DOI: 10.1188/15.CJON.196-203. View

16.

Rosenthal A, Israilevich R, Moy R . Management of acute radiation dermatitis: A review of the literature and proposal for treatment algorithm. J Am Acad Dermatol. 2019; 81(2):558-567. DOI: 10.1016/j.jaad.2019.02.047. View

17.

Wei J, Meng L, Hou X, Qu C, Wang B, Xin Y . Radiation-induced skin reactions: mechanism and treatment. Cancer Manag Res. 2019; 11:167-177. PMC: 6306060. DOI: 10.2147/CMAR.S188655. View

18.

Menon A, Prem S, Kumari R . Topical Betamethasone Valerate As a Prophylactic Agent to Prevent Acute Radiation Dermatitis in Head and Neck Malignancies: A Randomized, Open-Label, Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2020; 109(1):151-160. DOI: 10.1016/j.ijrobp.2020.08.040. View

19.

Hengge U, Ruzicka T, Schwartz R, Cork M . Adverse effects of topical glucocorticosteroids. J Am Acad Dermatol. 2005; 54(1):1-15. DOI: 10.1016/j.jaad.2005.01.010. View

20.

Ho A, Olm-Shipman M, Zhang Z, Siu C, Wilgucki M, Phung A . A Randomized Trial of Mometasone Furoate 0.1% to Reduce High-Grade Acute Radiation Dermatitis in Breast Cancer Patients Receiving Postmastectomy Radiation. Int J Radiat Oncol Biol Phys. 2018; 101(2):325-333. DOI: 10.1016/j.ijrobp.2018.02.006. View