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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT02556632
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ
* Subjects must be prescribed and scheduled for "conventional fractionated" RT without concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular nodes, axillary nodes, etc) as part of their prescribed radiation therapy are permitted; conventional fractionated radiation therapy regimens eligible for study are described below:
* Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy
* Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed = whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy
* Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy
* Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy
* Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy
* Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy
* Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy
* Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy
* Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT; (NOTE: surgery is not required for eligibility)
* Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is required between end of chemotherapy and start of RT
* Subjects may be currently prescribed hormone treatment or Herceptin therapy
* Subjects must be able to read, speak, and understand English
* Subjects must have the ability to understand and the willingness to sign a written informed consent document
* Subjects must agree to not use any other topical agents on skin in the radiation treatment area during the course of this trial; subjects should only use topical agents for the study (i.e., topical intervention or standard care agents) supplied by the study personnel and/or treating physician
Exclusion Criteria:
* Pregnant females are ineligible; all subjects of childbearing potential will be asked if they are pregnant or could be pregnant; the patient must respond "no" to continue with radiation and to participate in this clinical study
* Subjects with bilateral breast cancer are not eligible
* Subjects receiving the short-course fractionation radiation therapy (i.e., 16 sessions or 20 sessions at 2.4 to 2.6 Gy fractions per session, with or without boost)
* Subject is currently on anti-EGFR (human epidermal growth factor receptor) therapy, such as Iressa (gefitinib) or Erbitux (cetuximab, C225)
* Previous radiation to the chest or breast
* Subjects with breast reconstruction prior to RT
* Previous diagnosis of radiosensitivity disorder (i.e., ataxia telangiectasia)
* Previous diagnosis of collagen vascular disorder or vasculitis
* Presence of unhealed surgical wounds in chest or breast region and/or breast infection
* Current daily application of a prescribed topical product to the skin within the RT area for an unrelated skin condition that cannot be discontinued during the participation in this clinical trial
* Presence of any active dermatological issues in radiation treatment area (i.e., fungal skin infection, dermatitis, psoriasis plaques, etc)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT02556632
Study Brief:
Protocol Section:
NCT02556632