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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT04520139
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • N-Acetyl-Cysteine — DRUG
    Given PO
  • Placebo — OTHER
    Given PO

Study Details

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).

Key Dates

First listed
Aug 20, 2020
Start date
May 21, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation
    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.
  • Experimental: Phase 2 Dose Expansion
    Patients will be randomized to receive NAC at the maximum tolerated dose or placebo.

Primary Outcome Measure

Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy [ Time Frame: From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first. ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-7883
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Daniela Bota, MD, PhD
[email protected]
877-827-8839

Find similar trials in Orange, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

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