NCT04520139RecruitingPhase 1/2
Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
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)
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 17 Aug 2020
- Start date
- 21 May 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of California, Irvine
- Diseases
- Ovarian cancer
- NCT number
- NCT04520139
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 102
- From 21 May 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Receipt of systemic immunosuppressive therapy
Other illness
- Has a history of dementia or other neurodegenerative disorders
- Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses
- Has an active infection requiring treatment
- Known immunosuppressive disease
- Has active systemic autoimmune diseases such as lupus
- Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
Other
- Presence of known brain metastases
- Pregnant of breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California, Irvine Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.