What this study is
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).
What's being tested
- N-Acetyl-Cysteine
Intervention · DRUG
- Placebo
Intervention · OTHER
Both interventions
Given PO
Study details
- Official title
- Phase I Dose-Escalating and Phase II Dose-Expansion Study of N-Acetyl-Cysteine (NAC) Administration to Ovarian Cancer Patients Receiving Platinum-Based Therapy (PBT) for the Mitigation of Chemotherapy-Related Cognitive Impairment (CRCI)
- Sponsor
- University of California, Irvine
- Conditions
- Ovarian Cancer · Cognitive Impairment
- Enrolling
- 102 people
- Starts
- 2026-05-21
- Est. completion
- 2027-12
- Design
- Double-blind, randomized, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States
- Daniela Bota, MD, PhD · Contact877-827-8839ucstudy@uci.edu
Recruiting
Study team
Sponsor
University of California, Irvine
Study ID 20205846
Principal investigator
Daniela Bota, MD, PhD
Chao Family Comprehensive Cancer Center
CONTACT
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
University of California Irvine Medical
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.