Acetylcysteine for the Mitigation of Chemotherapy-Related Cognitive Impairment in Ovarian Cancer Patients Receiving Platinum-Based Therapy
- Patients and/or their legally authorized representative will sign informed consent forms for study participation before undergoing treatment
- Women with a histologically confirmed diagnosis of stage III–IV epithelial ovarian cancer that are prescribed at least six courses of platinum-based therapy. The patients will be recruited from the Gynecological Oncology Clinics of the Chao Family Comprehensive Cancer Center at UC Irvine. Our Gynecological Oncology Program is one of the largest in the United States, and is fully supportive of this study. Our projected enrollment will be completed over a period of 4 years
- 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
- 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
- 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
I. Determine the maximum tolerated dose (MTD) of acetylcysteine (NAC) in ovarian cancer patients receiving platinum-based therapy, using a phase I, dose-escalating design.
II. Evaluate the efficacy of NAC in ameliorating chemotherapy-related cognitive impairment (CRCI) in ovarian cancer patients receiving platinum-based therapy, using a phase II randomized, double-blinded, placebo-controlled study design.
OUTLINE: This is a phase I, dose-escalation trial of acetylcysteine followed by a phase II randomized trial. Patients are randomized to 1 of 2 arms.
ARM I: Patients receive acetylcysteine orally (PO) three times daily (TID) on days 1 and 5-21 and cisplatin or carboplatin on day 1. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO TID on days 1 and 5-21 and cisplatin or carboplatin on day 1. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of trial treatment, patients are followed up at 6 months.
Trial Phase Phase I/II
Trial Type Treatment
UC Irvine Health / Chao Family Comprehensive Cancer Center
Daniela A. Bota
- Primary ID UCI 18-120
- Secondary IDs NCI-2020-07167, 2020-5846
- Clinicaltrials.gov ID NCT04520139