This study is not yet accepting patients

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

a study on Ovarian Cancer Cognitive Impairment Ovarian Epithelial Carcinoma

Summary

Eligibility
for females ages 18 years and up (full criteria)
Dates
study started
completion around
Principal Investigator
by Daniela A. Bota (uci)

Description

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).

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)

Keywords

Ovarian Cancer, Cognitive Impairment, Chemotherapy-Related Cognitive Impairments, Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Chemotherapy-Related Cognitive Impairment, Cognitive Dysfunction, Acetylcysteine, N-monoacetylcystine, N-Acetyl-Cysteine

Eligibility

You can join if…

Open to females ages 18 years and up

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.

You CAN'T join if...

  • 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.

Lead Scientist at University of California Health

  • Daniela A. Bota (uci)
    Professor, Neurology, School of Medicine. Authored (or co-authored) 98 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT04520139
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 102 study participants
Last Updated