Clinical trial NCT04520139: Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Cognitive Impairment
Keywords: Chemotherapy-Related Cognitive Impairments
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Jarrow Formulas Inc
First posted: 2020-08-20
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1 will be a dose-escalating design.

Phase 2 will be a randomized, double-blinded, placebo-controlled study design
Primary purpose: TREATMENT

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).


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:

  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.

Primary outcomes:
measure: Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy
timeFrame: 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.
measure: Recommended Phase 2 Dose for NAC administered with PBT
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Daniela Bota, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: