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)
University of California, Irvine
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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. Leuk…
Interventions
- DrugN-Acetyl-Cysteine
Given PO
- OtherPlacebo
Given PO
Location
- Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, California