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NCT04520139 | NOT YET RECRUITING | Ovarian Cancer

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

University of California, Irvine

Information provided by (Responsible Party):

Daniela A. Bota

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).

Condition or disease

Ovarian Cancer

Cognitive Impairment

Intervention/treatment

N-Acetyl-Cysteine

Placebo

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 102 participants
Masking : DOUBLE
Masking Description : Phase 1 will be open label. Phase 2 will be be double-blinded.
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
    • 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.
Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT

Location Details

NCT04520139

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