Protocol No.UW25061
Principal InvestigatorBarroilhet, Lisa
PhaseN/A
Age GroupAdult
ClinicalTrials.GovNCT07125209 (Click to jump to clinicaltrials.gov)
Management Group(s) Palliative Care

Title
Cognitive impact of neoadjuvant chemotherapy for ovarian cancer

Description
Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer

Objective
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.

Treatment 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.

Key Eligibility 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

Applicable Disease Sites
Ovary

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital