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

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Irvine
• Collaborator: Jarrow Formulas Inc
• Treatments: Acetylcysteine; N-monoacetylcystine

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.