Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
N-Acetyl-Cysteine
DrugGiven PO
Placebo
Other interventionGiven PO
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Phase 1 Dose EscalationExperimental treatment 1 intervention
Group B: Phase 2 Dose ExpansionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy
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.
Time frame
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.2
Recommended Phase 2 Dose for NAC administered with PBT
Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding NAC to PBT.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Irvine
Lead sponsor
Jarrow Formulas Inc
Collaborator
Source ClinicalTrials.gov