Cognitive Changes in Adult Cancer Survivors

Completed

Conditions studied: Effects of Chemotherapy, Cognitive Impairment

In brief

This study will document the cognitive (mental) and functional abilities of newly diagnosed cancer patients. The study will also examine the changes in cognitive and functional abilities during and after chemotherapy (your cancer treatment). A comprehensive set of questionnaires and tasks, or assessments, have been put together in order for doctors and nurses to learn more about the day to day functioning of newly diagnosed adult cancer patients. The investigators would also like to follow up with the same adult patients, during and following completion of their cancer treatment, to learn about the kinds of treatments they received and how their cognitive status and level of participation in activities of daily living has changed. With follow-up assessments, doctors and nurses can learn more about the complications or health problems that adult patients may experience as a result of undergoing cancer therapy. This is a study involving two visits. The first visit occurs within two weeks before starting your cancer therapy, specifically chemotherapy. The second visit occurs within two weeks of completing your chemotherapy.

Key facts

Study ID

NCT01569932

Run by

Washington University School of Medicine

People needed

13

Starts

2011-02-01

Expected to finish

2013-01-01

Last updated by the study team

2013-02-26

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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