NCT07125209

Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 18 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-08-15
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States