Clinical trial NCT04173247: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Radiation Dermatitis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: KeraNetics, LLC
name: National Cancer Institute (NCI)
First posted: 2019-11-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Completion Rate of Use of KeraStat Cream
timeFrame: Up to 1 month post treatment with radiation therapy (6-7 weeks)
Secondary outcomes:
measure: Number of Participants Discontinuing Skin Care Regimen
timeFrame: Up to 1 month post treatment with radiation therapy (6-7 weeks)
measure: Number of Participants With Grade 2+ Radiation Dermatitis
timeFrame: Up to 1 month post treatment with radiation therapy (6-7 weeks)
measure: Number of Participants Reporting Radiation Skin Reaction
timeFrame: Up to 1 month post treatment with radiation therapy
measure: Dermatology Life Quality Index Questionnaire
timeFrame: At weeks 1-6 and up to 1 month post treatment with radiation therapy
measure: Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage
timeFrame: Up to 1 month post treatment with radiation therapy (7 weeks)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ryan Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References: