Status:
NOT_YET_RECRUITING
Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Jarrow Formulas Inc
Conditions:
Ovarian Cancer
Cognitive Impairment
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 canc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04520139
Start Date
December 1 2025
End Date
December 1 2027
Last Update
February 13 2025
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