Spots Global Cancer Trial Database for Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

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Trial Identification

Brief Title: Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

Official Title: Pilot Study of KeraStat® Cream for Radiation Dermatitis During Head and Neck Radiotherapy

Study ID: NCT04173247

Conditions

Head and Neck Cancer

Radiation Dermatitis

Interventions

KeraStat Cream

Routine Skin Care - Commercially Available Agents

Study Description

Brief Summary: This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck. Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.

Detailed Description: Primary Objective(s) • To determine the feasibility of the use of KeraStat Cream in patients receiving radiotherapy for head and neck cancer. Secondary Objective(s) * To determine the tolerability of KeraStat Cream in patients receiving radiotherapy for head and neck cancer compared to routine skin care. * To assess the effectiveness of KeraStat Cream in reducing the severity of EASR in patients receiving radiotherapy for head and neck cancer, compared to routine skin care. This will be performed by evaluating: * Objective evaluation of EASR using the CTCAE Version 5.0 scale of radiation dermatitis, * Patient-reported outcomes of radiation dermatitis using the PRO-CTCAE version 1.0, and * Dermatologic-specific quality of life assessment * To estimate the amount of KeraStat Cream used per patient and coverage on the skin.