Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer

NCT ID: NCT07125209

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-11-30

Brief Summary

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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

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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

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Ovarian Cancer Cognitive Change

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Receiving Neoadjuvant Chemotherapy for Ovarian Cancer

Patient Reported Outcomes Assessment

Intervention Type OTHER

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 Assessments

Intervention Type OTHER

* 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

Interventions

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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.

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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FACT-O FACT-Cog

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Barroilhet, MD

Role: PRINCIPAL_INVESTIGATOR

UW Carbone Cancer Center

Locations

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UW Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Central Contacts

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Supportive Oncology

Role: CONTACT

Phone: (608)263-6002

Email: [email protected]

Other Identifiers

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SMPH/OB-GYN/GYN ONCOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 7/23/25

Identifier Type: OTHER

Identifier Source: secondary_id

UW25061

Identifier Type: OTHER

Identifier Source: secondary_id

2025-1115

Identifier Type: -

Identifier Source: org_study_id