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Riluzole for Cancer-Related Cognitive Impairment

Phase 2

Recruiting

Led By Alexandre Chan, PharmD, MPH

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Not receiving chemotherapy, radiotherapy, and/or surgery during the study

* ≥18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

"This trial is testing whether riluzole treatment can affect the levels of BDNF in breast cancer survivors who are experiencing cognitive issues due to their cancer treatment."

Who is the study for?

This trial is for breast cancer survivors over 18 who feel their cognitive abilities have declined since diagnosis or treatment. They must not be undergoing current cancer treatments but should have had past chemotherapy, radiotherapy, or surgery.

What is being tested?

The study tests if Riluzole can improve brain function in these individuals compared to a placebo. It's a phase 2a trial where participants are randomly assigned to receive either the drug or an inactive substance without knowing which one they get.

What are the potential side effects?

While specific side effects aren't listed here, Riluzole typically may cause dizziness, gastrointestinal discomfort, and elevated liver enzymes. Placebo pills usually have no active ingredients and therefore minimal risk of side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not undergoing chemotherapy, radiotherapy, or surgery during the study.

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I am 18 years old or older.

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I have been diagnosed with breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in breast cancer survivors experiencing cognitive impairment (CRCI)

Secondary study objectives

Cognitive Function Scores (CANTAB)

Cognitive Function Scores (FACT-Cog)

Side effects data

From 2008 Phase 4 trial • 26 Patients • NCT00419003

38%

Fatigue

38%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Placebo Pre-Treatment

Lamotrigine Pre-Treatment

Riluzole Group

Ketamine

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RiluzoleExperimental Treatment1 Intervention

Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks

Group II: PlaceboPlacebo Group1 Intervention

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 8 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Riluzole

2006

Completed Phase 4

~2780

0 / 3Eligibility criteria met