Cognitive Impairment, Ovarian Cancer
Conditions
Keywords
Chemotherapy-Related Cognitive Impairments
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).
Interventions
Given PO
OTHERPlacebo
Given PO
Sponsors
University of California, Irvine
Jarrow Formulas Inc
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Phase 1 will be open label. Phase 2 will be be double-blinded.
Intervention model description
Phase 1 will be a dose-escalating design. Phase 2 will be a randomized, double-blinded, placebo-controlled study design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy | From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first. | Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding N-Acetyl-Cysteine (NAC) in ovarian cancer patients who are also receiving platinum-based therapy (PBT), using a Phase I, dose-escalating design. |
| Recommended Phase 2 Dose for NAC administered with PBT | From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first. | Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding NAC to PBT. |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORDaniela Bota, MD, PhD
Chao Family Comprehensive Cancer Center
Outcome results
None listed