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

NCT04520139 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 20205846UCI 18-120
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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

Keywords

Chemotherapy-Related Cognitive Impairments

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy

  Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding N-Acetyl-Cysteine (NAC) in ovarian cancer patients who are also receiving platinum-based therapy (PBT), using a Phase I, dose-escalating design.

  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.

• Recommended Phase 2 Dose for NAC administered with PBT

  Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding NAC to PBT.

  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.

Study Arms (2)

Phase 1 Dose Escalation

EXPERIMENTAL

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.

Drug: N-Acetyl-Cysteine

Phase 2 Dose Expansion

EXPERIMENTAL

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

Drug: N-Acetyl-Cysteine; Other: Placebo

Interventions

N-Acetyl-Cysteine DRUG

Given PO

Also known as: NAC Sustain, NAC

Phase 1 Dose Escalation; Phase 2 Dose Expansion

Placebo OTHER

Given PO

Phase 2 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study targets post-menopausal women with a histologically confirmed diagnosis of stage III-IV eipithelial ovarian cancer, fallopian tube, or primary peritoneal cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Hemoglobin \> 9 g/dL
• Leukocytes \>1,500/mcl
• Absolute Neutrophil Count \> 1,000/mcL
• Platelets \> 125,00/mcL
• total bilirubin Within normal institutional limits
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2.5 x institutional upper limit of normal
• Serum creatinine \< 1.5 mg/dL.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Jarrow Formulas Inc: collaborator

MeSH Terms

Conditions

Ovarian Neoplasms; Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Daniela Bota, MD, PhD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-7883; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Phase 1 will be open label. Phase 2 will be be double-blinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Phase 1 will be a dose-escalating design. Phase 2 will be a randomized, double-blinded, placebo-controlled study design

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04