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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT03768492
Eligibility Criteria:
Inclusion Criteria:
* Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)
* Patient has undergone mastectomy with tissue expander-based reconstruction and require post-mastectomy radiation therapy (PMRT) per the - Stage DCIS (0) -III breast cancer, excluding any patients with inflammatory breast cancer at presentation.
* Patient will receive irradiation of the chest wall. Additional fields to treat the regional nodes including the supraclavicular / axillary and/or internal mammary chains is allowed but not required. If a patient requires a boost field to the chest wall, scar and/or nodal region this is allowed.
Exclusion Criteria:
* Patient with skin changes or inflammatory carcinoma at presentation Patient has (cT4b-d)
* unhealed wound in the radiation field
* Patient has allergy to Caffeine
* Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development
* Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Trastuzumab)
* Planned accelerated or hypofractionated fractionation.
* Previous radiation to the ipsilateral breast or chest wall or thoracic region.
* Anyone who will require bolus use during radiation (per physician discretion) as this will increase rates of acute toxicity interfering with measurement of the primary study endpoint.
* All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03768492
Study Brief:
Protocol Section:
NCT03768492