N-Acetyl-Cysteine for Cognitive Impairment in Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Daniela Bota, MD, PhD
Principal Investigator
Chao Family Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for post-menopausal women with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer who have had or will have surgery and are set to receive at least six cycles of platinum-based chemotherapy. Participants must be in generally good health with adequate blood counts.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- N-Acetyl-Cysteine
- Placebo
Trial Overview
The study tests if adding N-Acetyl-Cysteine (NAC) to standard platinum-based chemotherapy can help prevent memory and thinking problems caused by chemo. Some participants get NAC while others get a placebo, and doses are adjusted for safety.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients will be randomized to receive NAC at the maximum tolerated dose or placebo.
Patients will receive NAC beginning at Cohort 1. If, at a given dose, none of the 3 patients shows a dose-limiting toxicity during the first cycle of PBT, then the dose is escalated 1 step for subsequent subjects. If, at a given dose, only 1 of 3 shows a dose-limiting toxicity, then up to 3 additional participants will be enrolled at that dose.If, at a given dose, the first 2, or any 2 of 3 subjects show a dose-limiting toxicity, then the dose will be de-escalated 1 step for future participants. At a dose where enrollment is expanded to between 4 and 6, if only 1 of 6 subjects shows a dose-limiting toxicity, then the dose will be escalated 1 step for future participants. However, if 2 or more of 4, 5, or 6participants show a dose-limiting toxicity, then the dose will be reduced one step for future participants. The maximum tolerated dose is defined as the highest dose not requiring deescalation. This is the dose to be used for the NAC arm of Phase II study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor
Jarrow Formulas Inc
Industry Sponsor
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