Clinical trial · Interventional
Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)
NCT07447050CI-TRIAL-00104474recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric (Stomach) Cancer | Childhood Gastric Carcinoma | ALIAS | 0.90 |
| Genitourinary Cancer | Malignant Genitourinary System Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Riluzole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Riluzole
- description
- Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for up to 6 months
- interventionNames
- Drug: Riluzole
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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 up to 6 months
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.