NCT07125209 · University of Wisconsin, Madison
Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer
What this study is about
The purpose of this research is to assess several components of cognition in patients recently diagnosed with advanced epithelial ovarian cancer and who will be undergoing neoadjuvant chemotherapy for treatment of the cancer. 18 participants will be enrolled and can expect to be on study for approximately 10 months.
View original scientific description
The purpose of this research is to assess several components of cognition in patients recently diagnosed with advanced epithelial ovarian cancer and who will be undergoing neoadjuvant chemotherapy for treatment of the cancer. 18 participants will be enrolled and can expect to be on study for approximately 10 months.
Interventions
OTHER
Patient Reported Outcomes Assessment
Functional Assessment of Cancer Therapy - Ovarian (FACT-O) and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess patient reported outcomes.
OTHER
Cognitive and General Health Assessments
* Rey Verbal Learning Test * Trail Making Test * Patient Health Questionnaire (PHQ-2) * Mini Mental State Exam (MMSE) * Controlled Oral Word Association Test of the Multilingual Aphasia Examination
Primary outcome measures
The Mini Mental State Exam (MMSE)
Time frame: baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)
The MMSE is a common overall test of cognition used in research and clinical settings. It is an 11 item test that assesses five domains of cognition: orientation, registration, attention, recall and language. This measure takes around 5-10 minutes to complete and is scored out of 30 with scores of 18-23 representing mild cognitive impairment and scores of 17 or less representing severe cognitive impairment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 or older
- Pathological diagnosis of suspected epithelial ovarian cancer; of note, patients with suspected epithelial ovarian cancer who are pending a pathological diagnosis/biopsy may be enrolled onto the study ahead of their biopsy. If the biopsy result is later inconsistent with epithelial ovarian cancer, they will be removed from the study and replaced
- Planned to received neoadjuvant chemotherapy with carboplatin and paclitaxel; alternatives to these agents including abraxane, docetaxel, cisplatin may be used if patients have a chemotherapy reaction or otherwise cannot receive carboplatin and paclitaxel per usual standard of care
- Patients may be receiving bevacizumab and may receive PARP inhibitors as a maintenance treatment; those receiving any other targeted therapy will be excluded
Exclusion criteria
- History of diagnosed cognitive impairment, including dementia
- History of traumatic brain injury
- English is not their primary language
- Known hearing or visual impairment not corrected with hearing devices and glasses/contacts
- Upper extremity motor impairment that would impact ability to perform the Trail Making Test
- Baseline Mini Mental State Exam (MMSE) score less than 18
Where
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations