Breast Cancer Clinical Trial
KeraStat(R) Cream for Radiation Dermatitis
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.
Full 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.
Eligibility Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.