Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer

NCT07125209 | Recruiting

• 4 other identifiers: 2025-1115SMPH/OB-GYN/GYN ONCOLOGYProtocol Version 7/23/25UW25061
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Cognitive Change

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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

  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)

  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)

  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)

  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)

Study Arms (1)

Receiving Neoadjuvant Chemotherapy for Ovarian Cancer

Other: Patient Reported Outcomes Assessment; Other: Cognitive and General Health Assessments

Interventions

Patient Reported Outcomes Assessment 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.

Also known as: FACT-O, FACT-Cog

Receiving Neoadjuvant Chemotherapy for Ovarian Cancer

Cognitive and General Health Assessments 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

Receiving Neoadjuvant Chemotherapy for Ovarian Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants scheduled to receive neoadjuvant chemotherapy for treatment of ovarian cancer.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

optional blood draw for research purposes

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Lisa Barroilhet, MD

  UW Carbone Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Supportive Oncology

CONTACT

(608)263-6002; supportiveoncology@uwcarbone.wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 15, 2025
• Study Start: April 28, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)