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

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).

Eligibility

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.

Conditions3

Interventions1

Locations1 site

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