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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how riluzole affects blood levels of a brain-related protein called BDNF, compared with a placebo (a treatment with no active drug). It is for adults whose thinking or memory has worsened after cancer treatment or radiation to the brain for tumors.

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 in cancer survivors (recently completing prior treatment regimens) or patients who have received whole brain radiation for benign or malignant tumors with cancer related cognitive impairment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • If you have not had brain radiation: you had treatment for breast cancer, or treatment for another cancer within the past 3 years.
  • If you have had brain radiation: it was for a tumor, whether cancer or not, and you are expected to live more than 6 months.
  • You or the study doctor think your thinking or memory has worsened since cancer treatment or brain radiation.
  • You can understand the study and agree to take part.
  • You can read and complete forms in English, Chinese, Korean, Vietnamese, or Spanish.
  • You agree to and can complete the forms and computer tests. If vision problems or a condition such as Parkinson’s disease prevents computer testing, you may still join if you can complete forms with help.
  • The study doctor will decide whether you need a break from other treatments and whether you can join another treatment study at the same time.

Who can't join

  • If you have not had brain radiation: you have or have had a tumor that started in the brain or cancer that spread to the brain.
  • If you have had brain radiation: you have a high-grade glioma, a fast-growing type of brain tumor.
  • You are not willing to take the required thinking and memory tests.
  • You are pregnant, breastfeeding, or planning to become pregnant during the study. If you could become pregnant and pregnancy is suspected, you must have a negative pregnancy test.
  • You have a history of a suspected allergy to riluzole or any of its ingredients.
  • You smoked within the past month, or take or plan to take pixantrone, abametapir, cannabis, capmatinib, lapatinib, methotrexate, or levoketoconazole.
  • Your liver blood tests called AST or ALT are at least 3 times the upper normal limit.
  • You have a serious existing health condition that the study doctor thinks would prevent you from taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Cohort-specific inclusion for male and female patients. a. Cohort A (no prior cranial radiation) i. 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. b. Cohort B (prior cranial radiation) * Previously received radiotherapy or radiosurgery to the brain for benign, malignant, or metastatic tumors. * Life expectancy \> 6 months 2. Washout from investigational and conventional 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. 3. ≥18 years of age 4. Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or cancer treatment. 5. Able to provide informed consent. 6. Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires. 7. 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: 1. Cohort-specific exclusion for male and female patients: 1. Cohort A (no prior cranial radiation) * History of or current presence of primary brain tumors or brain metastases. 2. Cohort B (prior cranial radiation) * Diagnosed with high grade glioma. 2. Unwilling to undergo neuropsychological assessments necessary for the study. 3. Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Persons of child-bearing potential (POCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy. a. Female 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. 4. History of suspected hypersensitivity to riluzole or to any of its excipients. 5. 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. 6. Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN) 7. Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Study sites (1)

CA