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

Primary Purpose

Head and Neck Cancer, Radiation Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KeraStat Cream
Routine Skin Care - Commercially Available Agents
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Wake Forest Baptist Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KeraStat Skin Cream Arm

Routine Skin Care Arm (RSC Arm)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage
Skin coverage is defined as the total number of tubes of KeraStat Cream used over 7 weeks OVER ALL participants in the KeraStat arm only.

Full Information

First Posted
November 20, 2019
Last Updated
August 29, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
KeraNetics, LLC, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04173247
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 Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
KeraNetics, LLC, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Radiation Dermatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KeraStat Skin Cream Arm
Arm Type
Experimental
Arm 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.
Arm Title
Routine Skin Care Arm (RSC Arm)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
KeraStat Cream
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Skin Care - Commercially Available Agents
Other Intervention Name(s)
Aveeno Skin Relief lotion, Eucerin, Lubriderm, Calendula cream or gel, Aloe vera gels, Cetaphil, CeraVe, Petroleum based with mineral oil ointments: Aquaphor, Balmex, Elta
Intervention Description
Commercially available skin moisturizers from an approved list that do not interfere with radiation.
Primary Outcome Measure Information:
Title
Completion Rate of Use of KeraStat Cream
Description
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 Outcome Measure Information:
Title
Number of Participants Discontinuing Skin Care Regimen
Description
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)
Title
Number of Participants With Grade 2+ Radiation Dermatitis
Description
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)
Title
Number of Participants Reporting Radiation Skin Reaction
Description
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
Title
Dermatology Life Quality Index Questionnaire
Description
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.
Time Frame
At weeks 1-6 and up to 1 month post treatment with radiation therapy
Title
Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage
Description
Skin coverage is defined as the total number of tubes of KeraStat Cream used over 7 weeks OVER ALL participants in the KeraStat arm only.
Time Frame
Up to 1 month post treatment with radiation therapy (7 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Hughes, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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