Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Texas Southwestern Medical Center
Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.
Age
18–99
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
