34 Participants Needed

Riluzole for Cancer-Related Cognitive Impairment

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Uo
Overseen ByUniversity of California Irvine Medical
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, Irvine
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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 of breast cancer survivors with cancer related cognitive impairment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are taking certain drugs like pixantrone, abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole. If you were part of another research study, a 30-day break from those treatments is required.

How is the drug Riluzole unique in treating cancer-related cognitive impairment?

Riluzole is unique because it is primarily used for treating amyotrophic lateral sclerosis (ALS) and works by modulating glutamate, a chemical in the brain that can affect nerve cells. This mechanism is different from other treatments for cancer-related cognitive impairment, which often focus on cognitive training or managing symptoms rather than directly targeting brain chemistry.12345

Research Team

AC

Alexandre Chan, PharmD, MPH

Principal Investigator

Chao Family Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I can understand and agree to the study's procedures and risks.
I am 18 years old or older.
I feel my thinking skills have declined since my cancer diagnosis or treatment.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 50 mg of riluzole or placebo twice daily for 8 weeks

8 weeks
3 visits (in-person) at baseline, midpoint, and endpoint

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Riluzole
Trial Overview 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.
Participant Groups
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

Riluzole is already approved in United States, European Union for the following indications:

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Approved in United States as Rilutek for:
  • Amyotrophic lateral sclerosis (ALS)
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Approved in European Union as Riluzole for:
  • Amyotrophic lateral sclerosis (ALS)
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Approved in United States as Tiglutik for:
  • Amyotrophic lateral sclerosis (ALS)
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Approved in United States as Exservan for:
  • Amyotrophic lateral sclerosis (ALS)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Findings from Research

Systemic cancer chemotherapy can lead to long-term cognitive deficits in survivors, affecting areas such as verbal learning, memory, attention, and information processing speed.
There is ongoing research into the mechanisms behind these cognitive deficits, including the potential role of genetic polymorphisms that may increase vulnerability to cognitive decline after chemotherapy.
Cognitive effects of cytotoxic cancer chemotherapy: predisposing risk factors and potential treatments.McAllister, TW., Ahles, TA., Saykin, AJ., et al.[2019]
A nationwide study involving 580 breast cancer patients showed significant cognitive decline in visual memory and other cognitive domains from prechemotherapy to 6 months postchemotherapy, indicating that cancer-related cognitive impairment (CRCI) is a persistent issue.
In contrast, 363 control participants did not experience cognitive changes over the same period, highlighting the specific impact of chemotherapy on cognitive function in breast cancer patients.
Longitudinal Trajectory and Characterization of Cancer-Related Cognitive Impairment in a Nationwide Cohort Study.Janelsins, MC., Heckler, CE., Peppone, LJ., et al.[2022]
A pilot study involving 21 breast and gynecologic cancer survivors showed that the Neuroflex cognitive enhancement program is feasible and well-accepted, with participants completing an average of 44.5 hours of training and achieving a 100% completion rate.
Participants reported significant improvements in cognitive function, including verbal learning and memory, as well as mood and disability assessments, suggesting that Neuroflex may effectively address chemotherapy-related cognitive impairment (CRCI).
Use of focused computerized cognitive training (Neuroflex) to improve symptoms in women with persistent chemotherapy-related cognitive impairment.Vega, JN., Newhouse, PA., Conley, AC., et al.[2023]

References

Cognitive effects of cytotoxic cancer chemotherapy: predisposing risk factors and potential treatments. [2019]
Longitudinal Trajectory and Characterization of Cancer-Related Cognitive Impairment in a Nationwide Cohort Study. [2022]
Use of focused computerized cognitive training (Neuroflex) to improve symptoms in women with persistent chemotherapy-related cognitive impairment. [2023]
The impact of cancer therapy on cognition in the elderly. [2021]
Chemotherapy-related cognitive impairment. [2022]