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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01569932
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be 40 years of age or older
* Subjects must be able to read, write and speak English fluently
* Treatment with a chemotherapy regimen that contains 5-fluorouracil or a platinum-based drug.
* Breast cancer subjects must be newly diagnosed with invasive lobular or ductal cancer (stages II and III)
* Head and Neck cancer subjects must be newly diagnosed with locally-advanced squamous cell carcinoma of the head and neck in oropharyngeal, hypopharyngeal and laryngeal sites (stages III and IV)
* Ovarian, fallopian tube, or primary peritoneal cancer subjects must be newly diagnosed with epithelial ovarian cancer (stages II - IV), fallopian tube cancer with pelvic extension (stages II-IV), or primary peritoneal cancer (stages III-IV)
* Bladder, renal pelvis, or ureteral cancer subjects must be newly-diagnosed with muscle-invasive cancer (stages II - IV).
* Urethral cancer subjects must be newly diagnosed with cancer invading the corpus spongiosum, prostate, or periurethral muscle (stages II-IV)
* Subjects must be anticipated to receive chemotherapy without the concomitant treatment use of hormonal therapy or immunomodulators.
Exclusion Criteria:
* Subjects with other prior cancer diagnoses who have evidence of active disease
* Subjects who have received chemotherapy or radiation treatment within the past year (for any disease state)
* Subjects with melanoma or other non-squamous cell carcinoma of the head and neck
* Subjects with nasopharyngeal, sinonasal or lateral skull base tumors. Unintentional cranial irradiation can occur with treatment to these sites and could therefore not be completely eliminated from being associated with any cognitive deficits observed.
* Subjects with implanted non-MRI compatible metal objects, electrodes, pacemakers, intracardiac lines, or medication pumps
* Subjects with weight over 350 pounds (weight limit on MRI machine)
* Subjects with a history of claustrophobia
* Subjects with an inability to lie flat for 20 minutes (for fcMRI scan)
* Life expectancy of less than 6 months
* Any medical condition the Principal Investigator (PI) determines would not make the study safe or in the best interest of the potential subject to participate in.
* Subjects who receive hormonal therapy therapy or immunomodulators as part of their cancer therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01569932
Study Brief:
Protocol Section:
NCT01569932