Ovarian CancerNCT07125209
Cognitive Impact of Neoadjuvant Chemotherapy for Gynecologic Cancers
An observational study of Ovarian Cancer and Cognitive Change, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Cognitive Change
- What is being tested?
- Patient Reported Outcomes Assessment and Cognitive and General Health Assessments
- Type of treatment
- Pill or oral medicine
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants scheduled to receive neoadjuvant chemotherapy for treatment of ovarian cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer
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.
Read the detailed description
Participants undergoing neoadjuvant chemotherapy for newly diagnosed, advanced epithelial ovarian cancer will be assessed for patient reported outcomes (including subjective cognitive impairment) and objective cognitive function at baseline, following three cycles of neoadjuvant chemotherapy, at the completion of adjuvant chemotherapy or transition to alternate treatment regimen for patients who progress through primary treatment, and six months following treatment completion. Patient reported outcomes will be assessed using the FACT-O and subjective cognitive impairment will be assessed using the FACT-Cog surveys.
The NCCN distress thermometer is used to screen for distress levels routinely in the gynecologic oncology clinic. For those who complete this screening as part of their clinical care, those results will also be used as a quality of life measure. The cognitive domains of learning and memory, processing speed, and executive function will be assessed using the Rey Verbal Learning Test, Trail Making Test, and the Controlled Oral Word Association of the Multilingual Aphasia Examination, as recommended by the International Cognition and Cancer Task force for studies of cognition in cancer patients.
- Conditions
- Ovarian Cancer, Cognitive Change
- Being tested
- Patient Reported Outcomes Assessment, Cognitive and General Health Assessments
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcomes AssessmentOther
Also called FACT-O, FACT-Cog
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.
Cognitive and General Health AssessmentsOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Receiving Neoadjuvant Chemotherapy for Ovarian Cancer | Not described Receives: Other: Patient Reported Outcomes Assessment; Other: Cognitive and General Health Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mini Mental State Exam (MMSE)
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.
Measured: 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)
Secondary outcomes (6)
Controlled Oral Word Association Test (COWAT)
Participant is asked to list as many words (other than people's names or places) beginning with a specific letter as they can in one minute. Number of unique words that qualify are counted.
Measured: 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)
Trail Making Test (TMT) Parts A and B
The TMT is a test of complex attention. Part A asks participants to connect circles on a page containing the numbers 1-25 in ascending order. Part B asks participants to connect circles containing the numbers 1-13 and the letters A-L in alternating ascending order (eg: 1, A, 2, B, etc). These tests are timed and a participant's score is the amount of time it takes to complete the entire task for each part; errors do not incur a score penalty but contribute to the overall time to complete the task. This takes approximately 5-10 minutes to complete
Measured: 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)
Patient Health Questionnaire-2 (PHQ-2)
The PHQ2 is a two item screening test that asks about the frequency of depressed mood and anhedonia over the past two weeks. Subjects whose answers receive a score of three or greater (on a scale of 0-6) are considered to be at risk for depression and should undergo further evaluation. This screening test takes around one minute to administer.
Measured: 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)
Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
The FACT-O is a validated and commonly used quality of life assessment utilized in many clinical research studies that assess 39 items/symptoms common amongst cancer patients generally with items included that are specifically common amongst ovarian cancer patients, including questions related to gastrointestinal symptoms and sexual health. Total scores range from 0 - 156 with higher scores indicative of better quality of life.
Measured: 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)
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)
The FACT-Cog is a patient reported outcomes measure assessing 37 cognitively-related symptoms, as well as their perceived impact on quality of life from the past 7 days. Scoring is from 0-4 in each of the following domains: perceived cognitive impairments, comments from others, perceived cognitive abilities, impact on quality of life. Total scores range from 0 -148 with higher scores indicating better perceived cognitive functioning.
Measured: 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)
Rey Auditory Verbal Learning Test (RAVLT)
The RAVLT is a test of immediate memory and verbal learning where participants are given three trials to recall as many words as possible from a 15-item list. Participants are asked to repeat this list one additional time after a 5-25 minute delay. This takes around 4 minutes to complete. Number of correct words from the list of 15 are reported for each trial.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start28 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Barroilhet, MD, Principal investigator, UW Carbone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125209
- Sponsor's protocol ID
- 2025-1115
- Other IDs
- SMPH/OB-GYN/GYN ONCOLOGY, Protocol Version 7/23/25, UW25061
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07125209
- Acronym / sponsor ID
- 2025-1115
- Conditions
- Ovarian Cancer, Cognitive Change
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants undergoing neoadjuvant chemotherapy for newly diagnosed, advanced epithelial ovarian cancer will be assessed for patient reported outcomes (including subjective cognitive impairment) and objective cognitive function at baseline, following three cycles of neoadjuvant chemotherapy, at the completion of adjuvant chemotherapy or transition to alternate treatment regimen for patients who progress through primary treatment, and six months following treatment completion. Patient reported outcomes will be assessed using the FACT-O and subjective cognitive impairment will be assessed using the FACT-Cog surveys.
The NCCN distress thermometer is used to screen for distress levels routinely in the gynecologic oncology clinic. For those who complete this screening as part of their clinical care, those results will also be used as a quality of life measure. The cognitive domains of learning and memory, processing speed, and executive function will be assessed using the Rey Verbal Learning Test, Trail Making Test, and the Controlled Oral Word Association of the Multilingual Aphasia Examination, as recommended by the International Cognition and Cancer Task force for studies of cognition in cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving Neoadjuvant Chemotherapy for Ovarian Cancer | – | Other: Patient Reported Outcomes Assessment, Other: Cognitive and General Health Assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants scheduled to receive neoadjuvant chemotherapy for treatment of ovarian cancer.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Reported Outcomes AssessmentAlso: FACT-O, FACT-CogFunctional 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 | Receiving Neoadjuvant Chemotherapy for Ovarian Cancer |
| 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 | Other | Receiving Neoadjuvant Chemotherapy for Ovarian Cancer |
Primary outcome
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.
6 secondary outcomes
Controlled Oral Word Association Test (COWAT)
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)
Trail Making Test (TMT) Parts A and B
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)
Patient Health Questionnaire-2 (PHQ-2)
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)
Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
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)
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)
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)
Rey Auditory Verbal Learning Test (RAVLT)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Barroilhet, MD principal investigator
UW Carbone Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Cognitive Change, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Supportive Oncology ((608)263-6002, supportiveoncology@uwcarbone.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.