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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 97319 | Other Identifier | IRB - Wake Forest University Health Science | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| KeraNetics, LLC | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KeraStat Skin Cream Arm | Experimental | 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. |
|
| Routine Skin Care Arm (RSC Arm) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KeraStat Cream | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 month post treatment with radiation therapy (6-7 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 month post treatment with radiation therapy (6-7 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Hughes, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 1 month post treatment with radiation therapy (6-7 weeks) |
|
Up to 1 month post treatment with radiation therapy (6-7 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal perforation | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Wake Forest Baptist Comprehensive Cancer Center | 336-716-4760 | jkettler@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2021 | Jul 10, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 20, 2021 | Dec 27, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C039909 | eucerin |
| D005782 | Gels |
| C011189 | cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion |
| D015034 | Zinc Oxide |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Routine Skin Care - Commercially Available Agents | Other | Commercially available skin moisturizers from an approved list that do not interfere with radiation. |
|
|
| 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. |
| 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. | 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. | At weeks 1-6 and up to 1 month post treatment with radiation therapy |
| 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. | Up to 1 month post treatment with radiation therapy (7 weeks) |
| Physician Decision |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 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. | Posted | Count of Participants | Participants | Up to 1 month post treatment with radiation therapy (6-7 weeks) |
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to 1 month post treatment with radiation therapy (6-7 weeks) |
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to 1 month post treatment with radiation therapy |
|
|
|
| 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. | Dlqi scores below are averaged over weeks 1-6 | Posted | Mean | Standard Deviation | units on a scale | At weeks 1-6 and up to 1 month post treatment with radiation therapy |
|
|
|
|
| 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. | Number of tubes over 7 weeks, in KeraStat arm only | Posted | Number | total number of tubes of KeraStat used | Up to 1 month post treatment with radiation therapy (7 weeks) |
|
|
|
| 1 |
| 12 |
| 3 |
| 12 |
| 2 |
| 12 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 3 | 12 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
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| Weight loss | Investigations | Non-systematic Assessment |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D007287 | Inorganic Chemicals |
| D017967 | Zinc Compounds |