Trial Outcomes & Findings for Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer (NCT NCT03374995)
NCT ID: NCT03374995
Last Updated: 2024-06-11
Results Overview
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.
COMPLETED
NA
25 participants
Up to 4 weeks post-RT
2024-06-11
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Group I (Topical Keratin)
n=13 Participants
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
|
Group II (Standard of Care)
n=11 Participants
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
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.15 Years
STANDARD_DEVIATION 9.5 • n=93 Participants
|
65.36 Years
STANDARD_DEVIATION 7.18 • n=4 Participants
|
62.0 Years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
11 participants
n=4 Participants
|
24 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks post-RTThe 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.
Outcome measures
| Measure |
Group I (Topical Keratin)
n=13 Participants
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
|
Group II (Standard of Care)
n=11 Participants
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
|
|---|---|---|
|
Incidence of Early Adverse Skin Reactions (EASRs)
Grade I Acute Radiation Dermatitis
|
13 Participants
|
10 Participants
|
|
Incidence of Early Adverse Skin Reactions (EASRs)
Grade II Acute Radiation Dermatitis
|
4 Participants
|
6 Participants
|
|
Incidence of Early Adverse Skin Reactions (EASRs)
Moist Desquamation
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 7 weeksA 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.
Outcome measures
| Measure |
Group I (Topical Keratin)
n=13 Participants
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
|
Group II (Standard of Care)
n=11 Participants
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
|
|---|---|---|
|
Change in Quality of Life
Visit 1 (baseline)
|
0.31 score on a scale
Standard Deviation 0.82
|
2.73 score on a scale
Standard Deviation 5.26
|
|
Change in Quality of Life
Visit 2
|
0.77 score on a scale
Standard Deviation 1.31
|
1.64 score on a scale
Standard Deviation 2.06
|
|
Change in Quality of Life
Visit 3
|
2.23 score on a scale
Standard Deviation 3.85
|
1.91 score on a scale
Standard Deviation 2.11
|
|
Change in Quality of Life
Visit 4
|
2.85 score on a scale
Standard Deviation 2.98
|
2.36 score on a scale
Standard Deviation 2.53
|
|
Change in Quality of Life
Visit 5
|
4.75 score on a scale
Standard Deviation 6.99
|
5.27 score on a scale
Standard Deviation 5.01
|
|
Change in Quality of Life
Visit 6
|
4.25 score on a scale
Standard Deviation 4.87
|
6.18 score on a scale
Standard Deviation 5.70
|
|
Change in Quality of Life
Visit 7
|
0.85 score on a scale
Standard Deviation 1.10
|
1.00 score on a scale
Standard Deviation 2.05
|
PRIMARY outcome
Timeframe: Baseline to up to 7 weeksSkin 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.
Outcome measures
| Measure |
Group I (Topical Keratin)
n=13 Participants
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
|
Group II (Standard of Care)
n=11 Participants
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
|
|---|---|---|
|
Physician Observed Improvement in Skin Appearance
Visit 1 (baseline)
|
0.00 units on a scale
Standard Deviation 0
|
0.00 units on a scale
Standard Deviation 0
|
|
Physician Observed Improvement in Skin Appearance
Visit 2
|
0.15 units on a scale
Standard Deviation 0.36
|
0.09 units on a scale
Standard Deviation 0.29
|
|
Physician Observed Improvement in Skin Appearance
Visit 3
|
0.62 units on a scale
Standard Deviation 0.49
|
0.55 units on a scale
Standard Deviation 0.50
|
|
Physician Observed Improvement in Skin Appearance
Visit 4
|
1.00 units on a scale
Standard Deviation 0.68
|
0.82 units on a scale
Standard Deviation 0.38
|
|
Physician Observed Improvement in Skin Appearance
Visit 5
|
1.17 units on a scale
Standard Deviation 0.55
|
1.00 units on a scale
Standard Deviation 0.43
|
|
Physician Observed Improvement in Skin Appearance
Visit 6
|
1.00 units on a scale
Standard Deviation 0
|
1.36 units on a scale
Standard Deviation 0.64
|
|
Physician Observed Improvement in Skin Appearance
Visit 7
|
0.23 units on a scale
Standard Deviation 0.42
|
0.30 units on a scale
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: Baseline to up to 7 weeksChange 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.
Outcome measures
| Measure |
Group I (Topical Keratin)
n=13 Participants
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
|
Group II (Standard of Care)
n=11 Participants
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
|
|---|---|---|
|
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Visit 1 (baseline)
|
2 Participants
|
4 Participants
|
|
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Visit 2
|
6 Participants
|
6 Participants
|
|
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Visit 3
|
8 Participants
|
8 Participants
|
|
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Visit 4
|
11 Participants
|
7 Participants
|
|
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Visit 5
|
11 Participants
|
10 Participants
|
|
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Visit 6
|
10 Participants
|
10 Participants
|
|
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Visit 7
|
7 Participants
|
2 Participants
|
Adverse Events
Group I (Topical Keratin)
Group II (Standard of Care)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal investigator
Wake Forest University Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place