BridgeMD
New treatment option for Breast Cancer
Official title Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
ClinicalTrials.gov ID: NCT06580002
What this study is testing
What is Riluzole?
Riluzole is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as RILUTEK.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Cohort-specific exclusion for male and female patients:
- Cohort A (no prior cranial radiation)
- History of or current presence of primary brain tumors or brain metastases.
- Cohort B (prior cranial radiation)
- Diagnosed with high grade glioma.
- Unwilling to undergo neuropsychological assessments necessary for the study.
See the full eligibility criteria
- 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
- 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...
- ≥18 years of age
- Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or 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...
- Cohort-specific exclusion for male and female patients:
- Cohort A (no prior cranial radiation)
- History of or current presence of primary brain tumors or brain metastases.
- Cohort B (prior cranial radiation)
- Diagnosed with high grade glioma.
- Unwilling to undergo neuropsychological assessments necessary for the study.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.