KeraStat(R) Cream for Radiation Dermatitis

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Age 18 to 70
Female
Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
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
Autoimmune disease
Skin disease in target irradiation area
Known allergy to the standard of care or ingredients in KeraStat Cream

Arm && Interventions

Group	Intervention	Description
KeraStat Cream	KeraStat(R) Cream	Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
Standard of care	Standard of care	Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.