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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)

UCI Specialty Area: Cancer
Principal Investigator: Daniela Bota
A Study On:
Ovary

Study Description

The purpose of this research study is to find out if NAC would be safe and effective in ovarian cancer patients who are simultaneously receiving chemotherapy with carboplatin and paclitaxel. We are also looking at whether NAC can prevent the development of chemotherapy-related cognitive impairments that some patients can experience after receiving chemotherapy. Some impairments, weakened or loss of function or ability, can include changes in memory, attention and problem-solving.

You will receive the chemotherapy for your ovarian cancer even if you were not in this trial. This trial is looking to add NAC in addition to your treatment. NAC is a dietary supplement that is not approved to treat CRCI.

NAC was previously tested on Alzheimer disease patients who did show better performance on tests compared to those who did not receive NAC. We would like to see if there are similar effects in patients with ovarian cancer.

The purpose of the study is to see if NAC is safe and can prevent or slow down chemotherapy-related cognitive changes in ovarian cancer patients.

Eligibility

You can participate in this study if you satisfy the following criteria:

At least 18 years of age

Have a diagnosis of ovarian cancer and have been prescribed platinum-based chemotherapy (chemotherapy agents that contains platinum)

You cannot participate in this study if you have any of the following criteria:

History of dementia

History of depression

Any active infection or other cancers

Pregnant or breastfeeding

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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