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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-02011 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 97417 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in patients with breast cancer.
PRIMARY OBJECTIVES:
I. To determine a preliminary estimate of the improvement of skin's natural barrier, decrease of dehydration, and reduction in the appearance of inflammation associated with radiation therapy (RT) skin toxicity as well as patients' satisfaction with their skin after the application of the medical device topical keratin (KeraStat Cream) during RT in breast cancer patients.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive topical keratin topically at least twice daily (BID) until the end of radiation therapy (approximately 3-6 weeks).
GROUP II: Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).
After completion of study treatment, patients are followed up at 4-6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (topical keratin) | Experimental | Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks). |
|
| Group II (standard of care) | Active Comparator | Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Early Adverse Skin Reactions (EASRs) | The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation. | Up to 4 weeks post-RT |
| Change in Quality of Life | A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure. | Baseline to up to 7 weeks |
| Physician Observed Improvement in Skin Appearance | Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure. | Baseline to up to 7 weeks |
| Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Winkfield | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Topical Keratin) | Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks). Quality-of-Life Assessment: Ancillary studies Topical Keratin: Given topically |
| FG001 | Group II (Standard of Care) | Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). Best Practice: Receive standard of care Quality-of-Life Assessment: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Topical Keratin) | Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks). Quality-of-Life Assessment: Ancillary studies Topical Keratin: Given topically |
| BG001 | Group II (Standard of Care) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of Early Adverse Skin Reactions (EASRs) | The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation. | Posted | Count of Participants | Participants | Up to 4 weeks post-RT |
|
Up to 30 days post radiation therapy
Expected side effects of radiation therapy that occurred at expected timeframes and severity (e.g., erythema, edema, desquamation) were not considered to be adverse events.
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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 | Group I (Topical Keratin) | Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks). Quality-of-Life Assessment: Ancillary studies Topical Keratin: Given topically |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal investigator | Wake Forest University Health Sciences | 336-716-5440 | kwinkfie@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 | Mar 1, 2018 | Nov 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Topical Keratin | Device | Given topically |
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| Baseline to up to 7 weeks |
Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). Best Practice: Receive standard of care Quality-of-Life Assessment: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Group II (Standard of Care) | Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). Best Practice: Receive standard of care Quality-of-Life Assessment: Ancillary studies |
|
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| Primary | Change in Quality of Life | A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline to up to 7 weeks |
|
|
|
| Primary | Physician Observed Improvement in Skin Appearance | Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline to up to 7 weeks |
|
|
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| Primary | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score. | Posted | Count of Participants | Participants | Baseline to up to 7 weeks |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Group II (Standard of Care) | Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). Best Practice: Receive standard of care Quality-of-Life Assessment: Ancillary studies | 0 | 11 | 0 | 11 | 0 | 11 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D003872 | Dermatitis |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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