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Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
Phase I Dose-Escalating and Phase II Dose-Expansion Study of N-Acetyl-Cysteine (NAC) Administration to Ovarian Cancer Patients Receiving Platinum-Based Therapy (PBT) for the Mitigation of Chemotherapy-Related Cognitive Impairment (CRCI)
Who can join
Ages 18 and older · Women
Full eligibility criteria
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.
About the study
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).
What is being tested
- N-Acetyl-Cysteine (drug)
- Placebo (other)
Sponsor: University of California, Irvine · Participants: 102 · Started: May 21, 2026
Contact the study team
- Chao Family Comprehensive Cancer Center University of California, Irvine · Phone: 1-877-827-7883
Official record on ClinicalTrials.gov — NCT04520139
Locations in the U.S.
| California | Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.