Head and Neck Cancer, Radiation Dermatitis
Conditions
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.
Interventions
DEVICEKeraStat Cream
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.
OTHERRoutine Skin Care - Commercially Available Agents
Commercially available skin moisturizers from an approved list that do not interfere with radiation.
Sponsors
KeraNetics, LLC
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate of Use of KeraStat Cream | Up to 1 month post treatment with radiation therapy (6-7 weeks) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Discontinuing Skin Care Regimen | Up to 1 month post treatment with radiation therapy (6-7 weeks) | 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 | Up to 1 month post treatment with radiation therapy (6-7 weeks) | 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 | Up to 1 month post treatment with radiation therapy | 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 | At weeks 1-6 and up to 1 month post treatment with radiation therapy | 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 | Up to 1 month post treatment with radiation therapy (7 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KeraStat Skin Cream Arm 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.
KeraStat Cream: 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. | 12 |
| Routine Skin Care Arm (RSC Arm) 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.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | KeraStat Skin Cream Arm | Routine Skin Care Arm (RSC Arm) | Total |
|---|---|---|---|
| Age, Continuous | 63.5 years | 64.5 years | 64 years |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 11 Participants | 21 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 12 | 0 / 12 |
| other Total, other adverse events | 2 / 12 | 3 / 12 |
| serious Total, serious adverse events | 3 / 12 | 0 / 12 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KeraStat Skin Cream Arm | Completion Rate of Use of KeraStat Cream | 10 Participants |
| Routine Skin Care Arm (RSC Arm) | Completion Rate of Use of KeraStat Cream | 7 Participants |
Secondary
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.
Time frame: At weeks 1-6 and up to 1 month post treatment with radiation therapy
Population: Dlqi scores below are averaged over weeks 1-6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KeraStat Skin Cream Arm | Dermatology Life Quality Index Questionnaire | 1.5 units on a scale | Standard Deviation 2.5 |
| Routine Skin Care Arm (RSC Arm) | Dermatology Life Quality Index Questionnaire | 1.9 units on a scale | Standard Deviation 2.5 |
p-value: 0.28t-test, 1 sided
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KeraStat Skin Cream Arm | Number of Participants Discontinuing Skin Care Regimen | 0 Participants |
| Routine Skin Care Arm (RSC Arm) | Number of Participants Discontinuing Skin Care Regimen | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KeraStat Skin Cream Arm | Number of Participants Reporting Radiation Skin Reaction | 8 Participants |
| Routine Skin Care Arm (RSC Arm) | Number of Participants Reporting Radiation Skin Reaction | 10 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KeraStat Skin Cream Arm | Number of Participants With Grade 2+ Radiation Dermatitis | 9 Participants |
| Routine Skin Care Arm (RSC Arm) | Number of Participants With Grade 2+ Radiation Dermatitis | 7 Participants |
Secondary
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.
Time frame: Up to 1 month post treatment with radiation therapy (7 weeks)
Population: Number of tubes over 7 weeks, in KeraStat arm only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| KeraStat Skin Cream Arm | Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage | 49 total number of tubes of KeraStat used |