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

Wake Forest University (WFU)

Status: Completed

Conditions: Radiation Dermatitis; Head and Neck Cancer

Treatments: Other: Routine Skin Care - Commercially Available Agents; Device: KeraStat Cream

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04173247

P30CA012197 (U.S. NIH Grant/Contract)

IRB00062012

WFBCCC 97319 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

KeraStat Skin Cream Arm

Experimental group

Description:

Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.

Treatment:

Device: KeraStat Cream

Routine Skin Care Arm (RSC Arm)

Active Comparator group

Description:

Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.

Treatment:

Other: Routine Skin Care - Commercially Available Agents