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Trial Title:
Repurposing Riluzole for Cancer-Related Cognitive Impairment: a Pilot Trial
NCT ID:
NCT06580002
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Cognitive Dysfunction
Riluzole
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Riluzole
Description:
Given PO
Arm group label:
Riluzole
Other name:
RILUTEK
Intervention type:
Drug
Intervention name:
Placebo
Description:
Given PO
Arm group label:
Placebo
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 breast cancer survivors with cancer related cognitive impairment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed with breast cancer
- Past exposure to chemotherapy, radiotherapy, and/or surgery
- Not receiving chemotherapy, radiotherapy, and/or surgery during the study
- ≥18 years of age
- Perceived that cognitive function has worsened since cancer diagnosis and/or
beginning of cancer treatment
- Able to provide informed consent
Exclusion Criteria:
- Presence of metastasis
- Unwilling to undergo neuropsychological assessments necessary for the study
- Breastfeeding, pregnant or are planning to get pregnant during the study period
- Suspected hypersensitivity to riluzole
- Patients taking these potential medications/substances due to drug-drug
interactions; based on specific agents listed in drug package insert (pixantrone,
current smoker, abametapir, cannabis, capmatinib, methotrexate, and
levoketoconazole)
- Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chao Family Comprehensive Cancer Center, University of California Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Contact:
Last name:
Alexandre Chan, PharmD, MPH
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Start date:
September 2024
Completion date:
September 2026
Lead sponsor:
Agency:
University of California, Irvine
Agency class:
Other
Source:
University of California, Irvine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06580002
