This phase I/II trial identifies the side effects and best dose of acetylcysteine and how well it works in reducing chemotherapy-related cognitive impairments in patients receiving platinum-based therapy (carboplatin or cisplatin) for ovarian cancer. Acetylcysteine is a dietary supplement that may lessen or slow down cognitive impairment such as changes in memory, attention and problem-solving. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving acetylcysteine in combination with carboplatin or cisplatin may lessen or prevent chemotherapy-related cognitive impairments in patients receiving platinum-based therapy for ovarian cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04520139.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer CenterStatus: Approved
Contact: Daniela A. Bota
Phone: 714-456-7214
PRIMARY OBJECTIVE:
I. Determine the maximum tolerated dose (MTD) of acetylcysteine (NAC) in ovarian cancer patients receiving platinum-based therapy, using a phase I, dose-escalating design.
II. Evaluate the efficacy of NAC in ameliorating chemotherapy-related cognitive impairment (CRCI) in ovarian cancer patients receiving platinum-based therapy, using a phase II randomized, double-blinded, placebo-controlled study design.
OUTLINE: This is a phase I, dose-escalation trial of acetylcysteine followed by a phase II randomized trial. Patients are randomized to 1 of 2 arms.
ARM I: Patients receive acetylcysteine orally (PO) three times daily (TID) on days 1 and 5-21 and cisplatin or carboplatin on day 1. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO TID on days 1 and 5-21 and cisplatin or carboplatin on day 1. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of trial treatment, patients are followed up at 6 months.
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
Principal InvestigatorDaniela A. Bota