Changes in Brain Function in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Pri… (NCT01080521) | Clinical Trial Compass
CompletedNot Applicable
Changes in Brain Function in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Are Receiving Chemotherapy
United States247 participantsStarted 2010-04
Plain-language summary
This clinical trial is studying changes in brain function in patients with stage I, stage II, stage III, or stage IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy. Learning about the effects of chemotherapy on brain function may help doctors plan cancer treatments.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or pathologically confirmed primary diagnosis of stage I-IV ovarian, primary peritoneal, or fallopian tube cancer (any cell type)
* Planning to receive ≥ 6 courses of front-line chemotherapy
* Have not yet received the first course of chemotherapy
* GOG performance status 0-2
* Able to read and understand English
* No uncontrolled or severe cardiovascular disease, including any of the following:
* Myocardial infarction within the past year
* Uncontrolled hypertension
* Congestive heart failure
* No history of head injury with GCS \< 13
* No severe hemiparesis or other condition preventing bimanual keyboard operation
* No distal neuropathy, action tremor, or other motor dysfunction that would substantially decrease keyboard accuracy
* No severe motor or mental slowing (i.e., patient who is disoriented/level C on any criterion as assessed by the person-place-time criteria)
* No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
* More than 6 months since prior epoetin alfa, darbepoetin, or any investigational forms of erythropoietin
* Patients may receive these agents during chemotherapy treatment as needed
* No prior radiotherapy or chemotherapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
Timeframe: Up to 6 months after completion of chemotherapy