Breast Carcinoma Clinical Trial
Official title:
A Randomized Intra-Patient Controlled Study of StrataXRT ® Versus Current Practice to Prevent and Treat Radiation Dermatitis
This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.
PRIMARY OBJECTIVE: I. Compare efficacy of silicone-based film forming topical gel (StrataXRT) versus (vs.) standard of care skin maintenance. SECONDARY OBJECTIVES: I. Evaluate overall effectiveness of StrataXRT. II. Evaluate post-radiation therapy (RT) recovery time for StrataXRT compared to standard of care. EXPLORATORY OBJECTIVES: I. To assess patient reported outcomes. II. Evaluate cost of StrataXRT for management of radiation dermatitis compared to standard of care skin maintenance. III. Evaluate the reduction in RT interruption/extension of overall duration of receiving RT based on the reduced skin toxicity. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1. ARM II: Patients receive standard of care including calendula and/or petrolatum-mineral oil-lanolin-ceresin ointment (Aquaphor) applied 2-6 times daily plus hydrogel or silver sulfadiazine (Silvadene) or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1. After completion of study, patients are followed up at 6 days and 3 weeks post-RT. ;
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