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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT04989504
Eligibility Criteria:
Inclusion Criteria:
* Histologic confirmation of breast malignancy with TNM staging.
* Patients must have undergone a mastectomy with or without reconstruction within the past 120 days if not receiving adjuvant therapy, or within 60 days after completion of the last dose of chemotherapy.
* No prior radiotherapy to any portion of the planned treatment site.
* No documented history of adhesive or tape allergy.
* Patients must be scheduled to receive conventionally fractionated photon-based radiation. Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation or hypofractionated radiation are not eligible.
* No active rash or pre-existing dermatitis within the treatment field.
* No co-existing medical conditions resulting in life expectancy \< 2 years.
* No active collagen vascular diseases (i.e. lupus erythematosus, scleroderma, dermatomyositis).
* No concomitant cytotoxic chemotherapy. Endocrine therapy and HER2 directed therapies are allowed.
* No current inflammatory breast cancer, or gross dermal involvement at initiation of radiotherapy.
* No previous history of organ or bone marrow transplant.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* In order to complete the mandatory patient-completed measures, participants must be able to speak and read English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04989504
Study Brief:
Protocol Section:
NCT04989504