RECRUITING

Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial

Conditions

Breast Cancer Sarcoma Gastric Cancer Lung Cancer Head and Neck Cancer Colorectal Cancer Ovarian Cancer Liver Cancer Genitourinary Cancer Gynecologic Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels of cancer survivors with cancer related cognitive impairment.

Official Title

Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial

Quick Facts

Study Start:2024-12-02

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06580002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Female and male patients diagnosed with one of the following: 1. Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions 2. Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years 3. Non-breast cancer patients exposed to other anticancer therapies within the past 3 years * Washout from investigational interventions is up to the discretion of the Investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study. * ≥18 years of age * Perceived by patient or investigator that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment * Able to provide informed consent. * Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires. * Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes.	* Presence of brain metastasis * Unwilling to undergo neuropsychological assessments necessary for the study. * Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy. * History of 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 or ALT ≥ 3x upper limit normal (ULN) * Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Inclusion Criteria

Exclusion Criteria

* Female and male patients diagnosed with one of the following:
1. Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions
2. Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years
3. Non-breast cancer patients exposed to other anticancer therapies within the past 3 years
* Washout from investigational interventions is up to the discretion of the Investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study.
* ≥18 years of age
* Perceived by patient or investigator that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment
* Able to provide informed consent.
* Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires.
* Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes.

* Presence of brain metastasis
* Unwilling to undergo neuropsychological assessments necessary for the study.
* Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy.
* History of 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 or ALT ≥ 3x upper limit normal (ULN)
* Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Principal Investigator

Alexandre Chan, PharmD, MPH

PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Alexandre Chan, PharmD, MPH, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-02

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-12-02

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer
Sarcoma
Gastric Cancer
Lung Cancer
Head and Neck Cancer
Colorectal Cancer
Ovarian Cancer
Liver Cancer
Genitourinary Cancer
Gynecologic Cancer