Radiation Dermatitis
Conditions
Brief summary
The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.
Detailed description
The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial. The secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin.
Interventions
DEVICEKeraStat(R) Cream
KeraStat Cream is a cream wound dressing that contains 5% keratin.
OTHERStandard of care
Patients will be instructed to follow institutional standard of care for radiation dermatitis
Sponsors
KeraNetics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 70 2. Female 3. Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more) 4. Able and willing to sign protocol consent form 5. Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes 6. Able and willing to have photographs of the affected area taken regularly
Exclusion criteria
1. Women who are pregnant, lactating/nursing or plan to become pregnant 2. Previous radiation therapy to the area to be treated with radiation therapy 3. Receiving palliative radiation therapy 4. Unhealed or infected surgical sites in the irradiation area 5. Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed) 6. Use of oral corticosteroids or topical corticosteroids in the irradiation area 7. Autoimmune disease 8. Skin disease in target irradiation area 9. Known allergy to the standard of care or ingredients in KeraStat Cream
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Therapy Oncology Group Skin Toxicity Scoring | Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks. | The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point. |
| Dermatology Life Quality Index | Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks. | The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks. | Evaluate safety and tolerability of application of KeraStat Cream through comparison of adverse events reported in KeraStat Cream group versus standard of care. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis | 11 |
| KeraStat Cream Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin. | 13 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard of Care | KeraStat Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Continuous | 65.4 years STANDARD_DEVIATION 7.5 | 59.2 years STANDARD_DEVIATION 9.9 | 62.0 years STANDARD_DEVIATION 9.3 |
| Dermatology Life Quality Index | 2.73 units on a scale STANDARD_DEVIATION 5.12 | 0.31 units on a scale STANDARD_DEVIATION 0.85 | 1.42 units on a scale STANDARD_DEVIATION 3.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 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 | 9 Participants | 11 Participants | 20 Participants |
| Radiation Therapy Oncology Group Skin Toxicity Grade (RTOG) | 0 units on a scale (RTOG) STANDARD_DEVIATION 0 | 0 units on a scale (RTOG) STANDARD_DEVIATION 0 | 0 units on a scale (RTOG) STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 11 participants | 13 participants | 24 participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 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 / 11 | 0 / 13 |
| other Total, other adverse events | 0 / 11 | 0 / 13 |
| serious Total, serious adverse events | 0 / 11 | 0 / 13 |
Outcome results
Primary
Dermatology Life Quality Index
The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups.
Time frame: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.
Population: One subject missed visit 5. One subject missed visit 6. Subject #18 missed visit 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Standard of Care | Dermatology Life Quality Index | Visit 3 | 1.91 units on a scale (DQLI score) |
| Standard of Care | Dermatology Life Quality Index | Visit 5 | 5.27 units on a scale (DQLI score) |
| Standard of Care | Dermatology Life Quality Index | Visit 2 | 1.64 units on a scale (DQLI score) |
| Standard of Care | Dermatology Life Quality Index | Visit 6 | 6.18 units on a scale (DQLI score) |
| Standard of Care | Dermatology Life Quality Index | Visit 4 | 2.36 units on a scale (DQLI score) |
| Standard of Care | Dermatology Life Quality Index | Visit 7 | 1.00 units on a scale (DQLI score) |
| Standard of Care | Dermatology Life Quality Index | Visit 1 | 2.73 units on a scale (DQLI score) |
| KeraStat Cream | Dermatology Life Quality Index | Visit 7 | 0.85 units on a scale (DQLI score) |
| KeraStat Cream | Dermatology Life Quality Index | Visit 1 | 0.31 units on a scale (DQLI score) |
| KeraStat Cream | Dermatology Life Quality Index | Visit 2 | 0.77 units on a scale (DQLI score) |
| KeraStat Cream | Dermatology Life Quality Index | Visit 3 | 2.23 units on a scale (DQLI score) |
| KeraStat Cream | Dermatology Life Quality Index | Visit 4 | 2.85 units on a scale (DQLI score) |
| KeraStat Cream | Dermatology Life Quality Index | Visit 5 | 4.75 units on a scale (DQLI score) |
| KeraStat Cream | Dermatology Life Quality Index | Visit 6 | 4.25 units on a scale (DQLI score) |
Primary
Radiation Therapy Oncology Group Skin Toxicity Scoring
The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point.
Time frame: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.
Population: One subject missed visit 5. One subject missed visit 6. Subject #18 missed visit 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Standard of Care | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 1 | 0.00 score on a scale |
| Standard of Care | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 5 | 1.00 score on a scale |
| Standard of Care | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 2 | 0.09 score on a scale |
| Standard of Care | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 6 | 1.36 score on a scale |
| Standard of Care | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 4 | 0.82 score on a scale |
| Standard of Care | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 7 | 0.30 score on a scale |
| Standard of Care | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 3 | 0.55 score on a scale |
| KeraStat Cream | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 7 | 0.23 score on a scale |
| KeraStat Cream | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 1 | 0.00 score on a scale |
| KeraStat Cream | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 2 | 0.15 score on a scale |
| KeraStat Cream | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 3 | 0.62 score on a scale |
| KeraStat Cream | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 4 | 1.00 score on a scale |
| KeraStat Cream | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 5 | 1.17 score on a scale |
| KeraStat Cream | Radiation Therapy Oncology Group Skin Toxicity Scoring | Visit 6 | 1.00 score on a scale |
Secondary
Number of Participants With Adverse Events
Evaluate safety and tolerability of application of KeraStat Cream through comparison of adverse events reported in KeraStat Cream group versus standard of care.
Time frame: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants With Adverse Events | 0 Participants |
| KeraStat Cream | Number of Participants With Adverse Events | 0 Participants |