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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04483856
Eligibility Criteria:
Inclusion Criteria:
* Women who give their written consent for participation in the study and willing to comply with all its procedures.
* Age ≥18 years.
* Women with breast cancer at any stage who have undergone quadrantectomy, for whom hypofractionated adjuvant RT of the thoracic region is indicated.
* RTOG/ EORTC radiodermatitis grade equal to 0 (zero) and good cutaneous trophism, in the region to be treated, according to investigator's judgement.
* Patients who are supposed to be cooperative with regard to compliance with study-related constraints.
Exclusion Criteria:
* Pregnant or lactating women (as not eligible to RT), and fertile women not following, at the investigators' judgement, an adequate contraceptive method.
* Subjects incapable of giving consent.
* Concomitant inflammatory skin diseases in acute phase such as: atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea.
* Collagen vascular disease, vasculitis, scleroderma, dermatomyositis, or systemic lupus erythematosus.
* Unhealed surgical sites, breast infections.
* Bilateral breast cancer or multiple neoplasia needing other independent RT treatments.
* Prior breast reconstructions, implants, and/or expanders.
* Known radio-sensitivity syndromes (e.g. ataxia-telangiectasia).
* Known history of intolerance or hypersensitivity to any ingredient of the study products.
* Previous RT in the same or different location.
* Topical pharmacological and medical device treatments on the skin region affected by the RT, in the last 2 weeks.
* Systemic or topical (including inhaled or intranasal) treatments containing corticosteroids of any class in the 2 days preceding the enrolment.
* Photo-therapy (PUVA, UVB) in the 2 weeks preceding the enrolment and/or planned to be administered during the course of the study.
* Participation in another clinical trial at the time of the randomization or within 28 days before randomization.
* Patient's difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04483856
Study Brief:
Protocol Section:
NCT04483856