Clinical trial · Observational
Cognitive Impact of Neoadjuvant Chemotherapy for Gynecologic Cancers
Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer
NCT07125209CI-TRIAL-00124100recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Change | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive and General Health Assessments | Other | — | UNRESOLVED |
| Patient Reported Outcomes Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Receiving Neoadjuvant Chemotherapy for Ovarian Cancer
- interventionNames
- Other: Patient Reported Outcomes Assessment
- Other: Cognitive and General Health Assessments
Primary outcomes (1)
- measure
- The Mini Mental State Exam (MMSE)
- timeFrame
- 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)
- description
- 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.
Secondary outcomes (6)
- measure
- Controlled Oral Word Association Test (COWAT)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.