Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT03374995
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03374995
Study Brief:
Protocol Section:
NCT03374995