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

NCT ID: NCT04520139

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

Brief 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).

Conditions

Ovarian Cancer; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

N-Acetyl-Cysteine

Intervention Type: DRUG

Given PO

Phase 2 Dose Expansion

Patients will be randomized to receive NAC at the maximum tolerated dose or placebo.

Group Type: EXPERIMENTAL

N-Acetyl-Cysteine

Intervention Type: DRUG

Given PO

Placebo

Intervention Type: OTHER

Given PO

Interventions

N-Acetyl-Cysteine

Given PO

Intervention Type: DRUG

Placebo

Given PO

Intervention Type: OTHER

Other Intervention Names

NAC Sustain; NAC

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jarrow Formulas Inc

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Daniela A. Bota

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Bota, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

1-877-827-7883

University of California Irvine Medical

Role: CONTACT

Other Identifiers

UCI 18-120

Identifier Type: OTHER

Identifier Source: secondary_id

20205846

Identifier Type: -

Identifier Source: org_study_id