Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer

University of Wisconsin (UW)

Status: Enrolling

Conditions: Cognitive Change; Ovarian Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT07125209

Protocol Version 7/23/25 (Other Identifier)

2025-1115

SMPH/OB-GYN/GYN ONCOLOGY (Other Identifier)

UW25061 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 1 patient group

Receiving Neoadjuvant Chemotherapy for Ovarian Cancer

Treatment:

Other: Cognitive and General Health Assessments

Other: Patient Reported Outcomes Assessment