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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Female and male patients diagnosed with one of the following:

‣ Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions

⁃ Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years

⁃ 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.

∙ 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.

Locations
United States
California
Chao Family Comprehensive Cancer Center, University of California Irvine
RECRUITING
Orange
Contact Information
Primary
Chao Family Comprehensive Cancer Center University of California, Irvine
ucstudy@uci.edu
1-877-827-8839
Backup
University of California Irvine Medical
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2027-12
Participants
Target number of participants: 51
Treatments
Experimental: Riluzole
Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks
Placebo_comparator: Placebo
Study participants randomized to this arm will take a placebo, that matches the appearance of 50 mg capsule of riluzole, twice daily (every 12 hours) for 8 weeks
Sponsors
Leads: University of California, Irvine

This content was sourced from clinicaltrials.gov