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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT00438659
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ
* Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:
* Whole breast (as part of breast-conservation therapy)
* Chest wall (as part of post-mastectomy irradiation)
* Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed
* Must meet the following criteria for planned radiotherapy:
* Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy
* No planned split-course radiotherapy
* No partial breast treatment, defined as treatment of \< 75% of the breast parenchyma
* Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed
* Must be entered on study within 7 days prior to beginning radiotherapy
* Must start study drug prior to receiving the third radiotherapy fraction
* No preexisting skin breakdown within the planned radiotherapy field at the time of study entry
* No bilateral breast cancer treatment
* No inflammatory carcinoma of the breast
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to complete questionnaires independently or with assistance
* No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy to the planned radiotherapy treatment area
* No concurrent or planned leukotriene inhibitors, including the following:
* Zafirleukast
* Monteleukast
* Zileuton
* No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments:
* Cortaid®
* Cortizone 10®
* Tucks®
* Preparation H®
* No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00438659
Study Brief:
Protocol Section:
NCT00438659