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:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT02165605
Eligibility Criteria:
Inclusion Criteria:
* Female, age 18 or older
* Diagnosis of breast cancer
* Intact breast (not surgically absent)
* Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)
* Ability to understand and comply with the requirements of this study
* Ability to give Informed Consent
* For sexually active females, patient agrees to use acceptable method of birth control
Exclusion Criteria:
* Women who are pregnant or lactating
* Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
* Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
* Severe renal failure creatinine \> 3.0 within 6 months of study registration
* Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
* Planned relocation which would make follow-up visits impossible during the course of the study
* Collagen vascular disease such as Lupus, or scleroderma
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02165605
Study Brief:
Protocol Section:
NCT02165605