24 Participants NeededMy employer runs this trial

Riluzole for Cognitive Dysfunction in Cancer

CF
Uo
Overseen ByUniversity of California Irvine Medical
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether riluzole can prevent memory and thinking problems in cancer patients receiving certain types of chemotherapy. Participants will take either riluzole, a medication, or a placebo, a pill with no active ingredients, for up to six months. The trial targets individuals diagnosed with cancer who are beginning chemotherapy that includes specific drugs like anthracycline or platinum. Those concerned about cognitive issues from treatment may find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with the trial drug, riluzole. Specifically, if you are taking pixantrone, abametapir, cannabis, capmatinib, lapatinib, methotrexate, or levoketoconazole, you might need to stop these medications. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that riluzole is likely to be safe for humans?

Research has shown that riluzole is generally safe and well-tolerated. The FDA has already approved it for another condition, providing doctors with extensive safety information. In previous studies, patients taking riluzole experienced few serious side effects. Common side effects include tiredness and dizziness, but these are usually mild and temporary. Importantly, riluzole has also been tested in cancer patients for similar reasons, and those studies confirmed its safety. Overall, evidence suggests that riluzole is safe for people, with manageable side effects.12345

Why do researchers think this study treatment might be promising for cognitive dysfunction in cancer?

Riluzole is unique because it targets cognitive dysfunction in cancer patients by modulating glutamate activity in the brain. Unlike traditional treatments which often focus on managing symptoms with therapies like cognitive rehabilitation or medications primarily designed for other conditions, riluzole works by reducing excessive glutamate, a neurotransmitter that can contribute to cognitive issues when present in high amounts. Researchers are excited about riluzole because it offers a new approach that could directly address the underlying neurobiological causes of cognitive dysfunction, potentially improving mental clarity and quality of life for cancer patients in a way that current options do not.

What evidence suggests that riluzole might be an effective treatment for cognitive dysfunction in cancer?

Research has shown that riluzole might help prevent cognitive problems in people receiving chemotherapy. In studies with mice, those treated with riluzole after chemotherapy performed better on memory tests. This improvement correlated with higher levels of brain-derived neurotrophic factor (BDNF), a protein that supports brain health. Riluzole, already approved for other uses, is believed to reduce brain inflammation, protecting against memory and thinking issues. This trial will evaluate riluzole's effectiveness in maintaining cognitive function in cancer patients undergoing chemotherapy, with participants receiving either riluzole or a placebo.24678

Who Is on the Research Team?

AC

Alexandre Chan, PharmD, MPH

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with cancer who are about to start chemotherapy containing anthracycline or platinum drugs, have a life expectancy over 6 months, and can complete questionnaires. People must be able to give consent.

Inclusion Criteria

* 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.
I have cancer and will receive anthracycline or platinum chemotherapy.
I am 18 years old or older.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either riluzole or placebo twice daily for up to 6 months

6 months
Regular visits for safety monitoring and cognitive assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Riluzole

Trial Overview

The study tests whether riluzole can help prevent memory and thinking problems caused by chemotherapy. Participants are randomly assigned to get either riluzole or a placebo without knowing which one they receive.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: RiluzoleExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Citations

BDNF Augmentation Using Riluzole Reverses Doxorubicin ...

Notably, in chemotherapy-exposed female mice, our data showed that treatment with RZ improves cognitive performance, along with other important observations ...

RiluzolE FOr Preventing Cognitive DysfUnction in Cancer ...

The purpose of this research study is to investigate whether riluzole therapy can help prevent cancer-related cognitive impairment ...

Riluzole for the Improvement of Brain-Derived Neuropathic ...

This phase II trial tests how well riluzole works in improving circulating brain-derived neurotrophic factor (BDNF) levels in cancer survivors with cancer ...

BDNF augmentation reverses cranial radiation therapy ...

Moreover, riluzole (RZ)-mediated increased BDNF in vivo in the chemotherapy-exposed mice reversed cognitive decline. RZ is an FDA-approved ...

Riluzole For Preventing Cognitive Dysfunction in Ca Pts ...

This is a phase II single-arm, Phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining efficacy of riluzole in preventing ...

Riluzole For Preventing Cognitive Dysfunction in Ca Pts ...

The study will assess the effects of riluzole on cognitive function ... Using International Cognition and Cancer Task Force (ICCTF criteria), overall cognitive ...

Pilot study tests ALS drug to treat chemo brain in cancer ...

The phase 2a clinical trial is also designed to evaluate the effect of riluzole on cognitive function in these patients over time, said ...

Riluzole for Cancer-Related Cognitive Impairment

This trial tests the drug riluzole to determine its effectiveness in addressing memory and thinking problems in cancer survivors.