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

Wake Forest University Health Sciences28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer Radiation Dermatitis

Interventions

KeraStat CreamDEVICE

KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.

Routine Skin Care - Commercially Available AgentsOTHER

Commercially available skin moisturizers from an approved list that do not interfere with radiation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of head and neck cancer planned to receive conventionally-fractionated definitive radiotherapy to the head and neck to a total prescribed dose of at least 60 Gy * Able and willing to sign protocol consent form * Able and willing to complete tolerability and quality of life assessments * Able and willing to have photographs of the affected area taken regularly Exclusion Criteria: * Women who are pregnant, lactating/nursing or plan to become pregnant * Previous radiation therapy to the area to be treated with radiation therapy * Active, medically necessary use of topical corticosteroids in the irradiation area * Active scleroderma or lupus requiring systemic medication * Treatment with anti-EGFR antibodies for head and neck cancer (previously or planned)

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Completion Rate of Use of KeraStat Cream

Feasibility of use of KeraStat Cream is measured by participant compliance with an average of 10 or more applications per week being classified as complaint. In each arm, a 95% confidence interval will be calculated around the estimate of compliance.

Time frame: Up to 1 month post treatment with radiation therapy (6-7 weeks)

Secondary Outcomes

Number of Participants Discontinuing Skin Care Regimen

Tolerability is measured by the number of patients who discontinue skin care regimen due to intolerance for any reason. In each arm, a 95% confidence interval will be calculated around the estimate of tolerability.

Time frame: Up to 1 month post treatment with radiation therapy (6-7 weeks)

Number of Participants With Grade 2+ Radiation Dermatitis

Objective assessment of early adverse skin reaction defined as Grade 2+ using the CTCAE version 5.0 scale of radiation dermatitis will be compared between the KeraStat group and the RSC group at the end of treatment, using a Fisher's exact test.

Time frame: Up to 1 month post treatment with radiation therapy (6-7 weeks)

Number of Participants Reporting Radiation Skin Reaction

Patient-reported assessment of skin toxicity using the PRO-CTCAE version 1.0 scale of radiation skin symptoms (skin dryness, itching, radiation skin reaction and skin darkening). Score scale is none to very severe and Yes or No for skin darkening.

Time frame: Up to 1 month post treatment with radiation therapy

Dermatology Life Quality Index Questionnaire

A 10-item questionnaire to measure how skin problems have affected participants' lives. Scoring for each question ranges from 0-3 with very much scored as 3 and not at all or not relevant score as 0. The DLQI is calculated by summing the score of each questions resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. The mean of the highest DLQI score across all time points will be compared between the KeraStat and RSC groups using a t-test.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.