Recruiting

Neoadjuvant Chemotherapy

Sponsor:

University of Wisconsin, Madison

Code:

NCT07125209

Conditions

Ovarian Cancer

Cognitive Change

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient Reported Outcomes Assessment

Cognitive and General Health Assessments

Study Details

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

Study ID

NCT07125209

Start date

Apr 28, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Interventions and Outcome Measures

Arms

Receiving Neoadjuvant Chemotherapy for Ovarian Cancer

Interventions

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.

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 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) ]

Central Contacts and Locations

Central contacts

Supportive Oncology

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

Locations

UW Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-27.