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NCT04520139PHASE1, PHASE2Recruiting

Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT

University of California, Irvine

Start Date

5/21/2026

Completion Date

12/1/2027

Summary

This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: Post-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy) * Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer * Eastern Cooperative Oncology Group (ECOG) ≤2 * Life expectancy \> 1 year * Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy * Prescribed a minimum of six cycles of platinum-based chemotherapy * Adequate organ function as defined below: 1. Hemoglobin \> 9 g/dL 2. Leukocytes \>1,500/mcl 3. Absolute Neutrophil Count \> 1,000/mcL 4. Platelets \> 125,00/mcL 5. total bilirubin Within normal institutional limits 6. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2.5 x institutional upper limit of normal 7. Serum creatinine \< 1.5 mg/dL. Exclusion Criteria: * Prior history of any cancer (other than non-melanoma skin cancer) * Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months * Prior severe head injury * Has a history of dementia or other neurodegenerative disorders * Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses * Presence of known brain metastases * Has an active infection requiring treatment * Known immunosuppressive disease * Has active systemic autoimmune diseases such as lupus * Receipt of systemic immunosuppressive therapy * Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C * Pregnant of breastfeeding.

Interventions

DRUG

N-Acetyl-Cysteine

OTHER

Placebo

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Conditions

Ovarian CancerCognitive Impairment

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California 92868

United States