Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, Irvine
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- N-Acetyl-Cysteine
- Placebo
Treatment groups
102 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University of California, Irvine
Lead sponsor
Jarrow Formulas Inc
Collaborator
Source ClinicalTrials.gov