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Recruiting NCT04520139

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

Phase I / Phase II Interventional Ovarian Cancer Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N-Acetyl-Cysteine, Placebo.
Who it may be relevant to
Registry conditions: Ovarian Cancer, Cognitive Impairment. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Phase I Dose-Escalating and Phase II Dose-Expansion Study of N-Acetyl-Cysteine (NAC) Administration to Ovarian Cancer Patients Receiving Platinum-Based Therapy (PBT) for the Mitigation of Chemotherapy-Related Cognitive Impairment (CRCI)

Overview

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

  • Drug N-Acetyl-Cysteine
    Given PO
  • Other Placebo
    Given PO

Primary outcome measures

  • Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy [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.]
  • Recommended Phase 2 Dose for NAC administered with 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.]

Eligibility 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:
  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange

Identifiers

NCT: NCT04520139 · 20205846 · UCI 18-120

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗