Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
study ends around
Principal Investigator
by Alexandre Chan
Headshot of Alexandre Chan
Alexandre Chan

Description

Summary

This is a phase II single-arm, Phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining efficacy of riluzole in preventing cognitive dysfunction in subjects with cancer, who are receiving chemotherapy.

Official Title

RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)

Keywords

Breast Cancer, Sarcoma, Gastric (Stomach) Cancer, Lung Cancer, Head and Neck Cancer, Colorectal Cancer, Ovarian Cancer, Liver Cancer, Genitourinary Cancer, Gynecologic Cancer, Breast Neoplasms, Stomach Neoplasms, Lung Neoplasms, Head and Neck Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Liver Neoplasms, Urogenital Neoplasms, Riluzole

Eligibility

You can join if…

Open to people ages 18 years and up

  • Female and male patients diagnosed with cancer and planned to receive an anthracycline- or platinum- containing chemotherapy regimen.
  • ≥18 years of age.
  • Life expectancy > 6 months
  • Able to provide informed consent.
  • Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes. Note: Patients who have visual impairment or have degenerative conditions (e.g. Parkinsons's disease, etc.) can participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.

You CAN'T join if...

  • Presence of primary brain tumors or brain metastases.
  • Receive a primary chemotherapy regimen that does not include anthracycline- or platinum- containing chemotherapy.
  • Unwilling to undergo neuropsychological assessments necessary for the study.
  • Patients who are breastfeeding, pregnant or are planning to get pregnant during the study period. POCBP must have a negative pregnancy test at screening if there is suspicion of pregnancy. Patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.
  • History of or suspected hypersensitivity to riluzole or to any of its excipients.
  • Patients taking or planned to take medications/substances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole.
  • Hepatic impairment as indicated by: AST and/or ALT ≥ 3 X upper limit normal (ULN).
  • Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Location

  • Chao Family Comprehensive Cancer Center, University of California Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Alexandre Chan
    Clinical Professor, Clinical Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences. Authored (or co-authored) 318 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT07447050
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 24 study participants
Last Updated