This trial studies how well Kerastat cream works in preventing radiation skin irritation (dermatitis) in patients with head and neck cancer undergoing radiation therapy. KeraStat cream is a wound dressing which promotes wound healing and provides protection from damage due to heat or radiation exposure. Applying Kerastat cream, may prevent and reduce the severity of radiation dermatitis. This study may provide information that could be used to create other studies with this cream in the future.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04173247.
PRIMARY OBJECTIVE:
I. To determine the feasibility of the use of topical keratin (KeraStat) cream in patients receiving radiotherapy for head and neck cancer.
SECONDARY OBJECTIVES:
I. To determine the tolerability of KeraStat cream in patients receiving radiotherapy for head and neck cancer compared to routine skin care.
II. To assess the effectiveness of KeraStat cream in reducing the severity of early adverse skin reaction (EASR) in patients receiving radiotherapy for head and neck cancer, compared to routine skin care.
IIa. Objective evaluation of EASR using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale of radiation dermatitis.
IIb. Patient-reported outcomes of radiation dermatitis using the patient reported outcomes (PRO)-CTCAE version 1.0.
IIc. Dermatologic-specific quality of life assessment.
III. To estimate the amount of KeraStat cream used per patient and coverage on the skin.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients apply topical keratin cream topically at least twice daily (BID) beginning on the first day of radiation therapy (RT) up to 1 month post-RT.
ARM II: Patients apply routine skin care topically at least BID beginning on the first day of RT up to 1 month post-RT.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorRyan T Hughes
