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

Ovarian Cancer Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04520139
• Other study ID #: 20205846
• Secondary ID: UCI 18-120
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2024
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: Chao Family Comprehensive Cancer Center University of California
• Phone: 1-877-827-7883
• Email: ucstudy[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Chemotherapy-Related Cognitive Impairment
• Cognitive Dysfunction
• Cognitive Impairment
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• N-Acetyl-Cysteine
Given PO

Other:
• Placebo
Given PO

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Jarrow Formulas Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy	Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding N-Acetyl-Cysteine (NAC) in ovarian cancer patients who are also receiving platinum-based therapy (PBT), using a Phase I, dose-escalating design.	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.
Primary	Recommended Phase 2 Dose for NAC administered with PBT	Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding NAC to PBT.	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.