Breast Carcinoma, Radiation-Induced Dermatitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERBest Practice
Receive standard of care
OTHERQuality-of-Life Assessment
Ancillary studies
DEVICETopical Keratin
Given topically
Sponsors
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
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+) * Area to be irradiated representing 1-10% of total body surface area (TBSA) * Able and willing to sign protocol consent form * Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes * 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 * Receiving palliative radiation therapy * Unhealed or infected surgical sites in the irradiation area * Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed) * Use of oral corticosteroids or topical corticosteroids in the irradiation area * Use of Erbitux * Autoimmune disease * Skin disease in target irradiation area * Smoker * Known allergy to the standard of care or ingredients in KeraStat Cream
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Early Adverse Skin Reactions (EASRs) | Up to 4 weeks post-RT | 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. |
| Change in Quality of Life | Baseline to up to 7 weeks | 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. |
| Physician Observed Improvement in Skin Appearance | Baseline to up to 7 weeks | 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. |
| Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Baseline to up to 7 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| 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 | 11 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group I (Topical Keratin) | Total | Group II (Standard of Care) |
|---|---|---|---|
| Age, Continuous | 59.15 Years STANDARD_DEVIATION 9.5 | 62.0 Years STANDARD_DEVIATION 9.3 | 65.36 Years STANDARD_DEVIATION 7.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 24 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 20 Participants | 9 Participants |
| Region of Enrollment United States | 13 participants | 24 participants | 11 participants |
| Sex: Female, Male Female | 13 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 11 |
| other Total, other adverse events | 0 / 13 | 0 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 11 |
Outcome results
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.
Time frame: Baseline to up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I (Topical Keratin) | Change in Quality of Life | Visit 7 | 0.85 score on a scale | Standard Deviation 1.1 |
| Group I (Topical Keratin) | Change in Quality of Life | Visit 1 (baseline) | 0.31 score on a scale | Standard Deviation 0.82 |
| Group I (Topical Keratin) | Change in Quality of Life | Visit 2 | 0.77 score on a scale | Standard Deviation 1.31 |
| Group I (Topical Keratin) | Change in Quality of Life | Visit 3 | 2.23 score on a scale | Standard Deviation 3.85 |
| Group I (Topical Keratin) | Change in Quality of Life | Visit 4 | 2.85 score on a scale | Standard Deviation 2.98 |
| Group I (Topical Keratin) | Change in Quality of Life | Visit 5 | 4.75 score on a scale | Standard Deviation 6.99 |
| Group I (Topical Keratin) | Change in Quality of Life | Visit 6 | 4.25 score on a scale | Standard Deviation 4.87 |
| Group II (Standard of Care) | Change in Quality of Life | Visit 7 | 1.00 score on a scale | Standard Deviation 2.05 |
| Group II (Standard of Care) | Change in Quality of Life | Visit 4 | 2.36 score on a scale | Standard Deviation 2.53 |
| Group II (Standard of Care) | Change in Quality of Life | Visit 1 (baseline) | 2.73 score on a scale | Standard Deviation 5.26 |
| Group II (Standard of Care) | Change in Quality of Life | Visit 6 | 6.18 score on a scale | Standard Deviation 5.7 |
| Group II (Standard of Care) | Change in Quality of Life | Visit 2 | 1.64 score on a scale | Standard Deviation 2.06 |
| Group II (Standard of Care) | Change in Quality of Life | Visit 5 | 5.27 score on a scale | Standard Deviation 5.01 |
| Group II (Standard of Care) | Change in Quality of Life | Visit 3 | 1.91 score on a scale | Standard Deviation 2.11 |
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.
Time frame: Up to 4 weeks post-RT
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I (Topical Keratin) | Incidence of Early Adverse Skin Reactions (EASRs) | Grade II Acute Radiation Dermatitis | 4 Participants |
| Group I (Topical Keratin) | Incidence of Early Adverse Skin Reactions (EASRs) | Grade I Acute Radiation Dermatitis | 13 Participants |
| Group I (Topical Keratin) | Incidence of Early Adverse Skin Reactions (EASRs) | Moist Desquamation | 1 Participants |
| Group II (Standard of Care) | Incidence of Early Adverse Skin Reactions (EASRs) | Grade I Acute Radiation Dermatitis | 10 Participants |
| Group II (Standard of Care) | Incidence of Early Adverse Skin Reactions (EASRs) | Grade II Acute Radiation Dermatitis | 6 Participants |
| Group II (Standard of Care) | Incidence of Early Adverse Skin Reactions (EASRs) | Moist Desquamation | 0 Participants |
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.
Time frame: Baseline to up to 7 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I (Topical Keratin) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 5 | 11 Participants |
| Group I (Topical Keratin) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 1 (baseline) | 2 Participants |
| Group I (Topical Keratin) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 2 | 6 Participants |
| Group I (Topical Keratin) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 3 | 8 Participants |
| Group I (Topical Keratin) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 4 | 11 Participants |
| Group I (Topical Keratin) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 6 | 10 Participants |
| Group I (Topical Keratin) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 7 | 7 Participants |
| Group II (Standard of Care) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 6 | 10 Participants |
| Group II (Standard of Care) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 4 | 7 Participants |
| Group II (Standard of Care) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 1 (baseline) | 4 Participants |
| Group II (Standard of Care) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 5 | 10 Participants |
| Group II (Standard of Care) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 2 | 6 Participants |
| Group II (Standard of Care) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 7 | 2 Participants |
| Group II (Standard of Care) | Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale | Visit 3 | 8 Participants |
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.
Time frame: Baseline to up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I (Topical Keratin) | Physician Observed Improvement in Skin Appearance | Visit 3 | 0.62 units on a scale | Standard Deviation 0.49 |
| Group I (Topical Keratin) | Physician Observed Improvement in Skin Appearance | Visit 5 | 1.17 units on a scale | Standard Deviation 0.55 |
| Group I (Topical Keratin) | Physician Observed Improvement in Skin Appearance | Visit 2 | 0.15 units on a scale | Standard Deviation 0.36 |
| Group I (Topical Keratin) | Physician Observed Improvement in Skin Appearance | Visit 6 | 1.00 units on a scale | Standard Deviation 0 |
| Group I (Topical Keratin) | Physician Observed Improvement in Skin Appearance | Visit 4 | 1.00 units on a scale | Standard Deviation 0.68 |
| Group I (Topical Keratin) | Physician Observed Improvement in Skin Appearance | Visit 7 | 0.23 units on a scale | Standard Deviation 0.42 |
| Group I (Topical Keratin) | Physician Observed Improvement in Skin Appearance | Visit 1 (baseline) | 0.00 units on a scale | Standard Deviation 0 |
| Group II (Standard of Care) | Physician Observed Improvement in Skin Appearance | Visit 7 | 0.30 units on a scale | Standard Deviation 0.46 |
| Group II (Standard of Care) | Physician Observed Improvement in Skin Appearance | Visit 1 (baseline) | 0.00 units on a scale | Standard Deviation 0 |
| Group II (Standard of Care) | Physician Observed Improvement in Skin Appearance | Visit 2 | 0.09 units on a scale | Standard Deviation 0.29 |
| Group II (Standard of Care) | Physician Observed Improvement in Skin Appearance | Visit 3 | 0.55 units on a scale | Standard Deviation 0.5 |
| Group II (Standard of Care) | Physician Observed Improvement in Skin Appearance | Visit 4 | 0.82 units on a scale | Standard Deviation 0.38 |
| Group II (Standard of Care) | Physician Observed Improvement in Skin Appearance | Visit 5 | 1.00 units on a scale | Standard Deviation 0.43 |
| Group II (Standard of Care) | Physician Observed Improvement in Skin Appearance | Visit 6 | 1.36 units on a scale | Standard Deviation 0.64 |