A feasibility study of an internal control methodology using hydrocortisone cream for the management of skin reactions in patients receiving radical radiation therapy for cancers of the head and neck

Background: The literature on the evaluation of the management of radiation-induced dermatitis demonstrates the methodological difficulties of studying this subject. Therefore, the feasibility of a methodology whereby the patient acted as their own control was used to study acute cutaneous side effects for head and neck radiotherapy patients using 1% hydrocortisone cream (HC). Methods: Twenty patients were asked to apply Hyderm (1% hydrocortisone) cream twice daily to one side of the treatment area (either right or left) beginning on day one of radiation therapy and ending 2 weeks post-radiation therapy. The centres standard skin care protocol using mild soap and water and no creams was used on the other side of the neck. Once weekly the patients were assessed and scored using the Radiation-Induced Skin Reaction Scale and Radiotherapy and Oncology Group assessment scales and the patient completed a symptom scoring scale each week was a baseline assessment undertaken before they started treatment. To document compliance with study instructions, patients were asked to keep a calendar indicating when they applied the cream and to which side, and this was collected by clinical staff. Results: At the conclusion of the study, 12 patients were enrolled. During the course of the study it became increasingly obvious that the side to which patients were applying the Hyderm scored higher on the assessment scale, indicating an increased skin reaction than the control side. This was confirmed with the photographs and patient symptom scale. As a result of these increased reactions, the study ceased accrual earlier than anticipated and all patients were advised to discontinue Hyderm use. Conclusion: The increase in skin toxicity was unexpected, particularly as the institutional standard of care recommended the use of HC as treatment for radiation dermatitis. The number of patients in the study was too small to make conclusive statements about the efficacy of HC. We were able to confirm the feasibility of using an internal control methodology in these patients. Compliance results indicate the skin care instructions were clearly written and patients were able to follow them.