NCT04520139 Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
| NCT ID | NCT04520139 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of California, Irvine |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2026-05-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 102 participants in total. It began in 2026-05-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Chao Family Comprehensive Cancer Center University of California, Irvine
✉ ucstudy@uci.edu📞 1-877-827-7883
Daniela Bota, MD, PhD
PRINCIPAL INVESTIGATOR
Chao Family Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT04520139 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04520139 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04520139 currently recruiting?
Yes, NCT04520139 is actively recruiting participants. Contact the research team at ucstudy@uci.edu for enrollment information.
Where is the NCT04520139 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT04520139 clinical trial?
NCT04520139 is sponsored by University of California, Irvine. The principal investigator is Daniela Bota, MD, PhD at Chao Family Comprehensive Cancer Center. The trial plans to enroll 102 participants.
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