Riluzole for Cancer-Related Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of California, Irvine
Must not be taking: Pixantrone, Cannabis, others
Disqualifiers: Metastasis, Pregnancy, Hepatic impairment, others
Prior Safety Data
Approved in 4 Jurisdictions
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.
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Trial 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 (Other)
Trial OverviewThe 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, United States, United States for the following indications:
🇺🇸 Approved in United States as Rilutek for:
- Amyotrophic lateral sclerosis (ALS)
🇪🇺 Approved in European Union as Riluzole for:
- Amyotrophic lateral sclerosis (ALS)
🇺🇸 Approved in United States as Tiglutik for:
- Amyotrophic lateral sclerosis (ALS)
🇺🇸 Approved in United States as Exservan for:
- Amyotrophic lateral sclerosis (ALS)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Chao Family Comprehensive Cancer Center, University of California IrvineOrange, CA
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Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor
Trials
580
Patients Recruited
4,943,000+
References
Cognitive effects of cytotoxic cancer chemotherapy: predisposing risk factors and potential treatments. [2019]Increasing evidence suggests that systemic cancer chemotherapy can have significant long-term effects on cognition, particularly on verbal learning, memory, attention, and speed of information processing. These deficits can be a source of significant distress to survivors. There is much less known about the mechanisms, predisposing vulnerabilities, and treatment of these deficits. We will summarize current knowledge of chemotherapy-associated cognitive deficits. Emerging theories about the role of selected genetic polymorphisms in heightening the vulnerability to chemotherapy-induced cognitive decline will be described.
Longitudinal Trajectory and Characterization of Cancer-Related Cognitive Impairment in a Nationwide Cohort Study. [2022]Cancer-related cognitive impairment (CRCI) is an important clinical problem in patients with breast cancer receiving chemotherapy. Nationwide longitudinal studies are needed to understand the trajectory and severity of CRCI in specific cognitive domains.
Use of focused computerized cognitive training (Neuroflex) to improve symptoms in women with persistent chemotherapy-related cognitive impairment. [2023]Chemotherapy-related cognitive impairment (CRCI) is a distressing and increasingly recognized long-term sequela reported by breast cancer patients following cancer treatment. There is an urgent but unmet clinical need for treatments that improve CRCI. In this context, we proposed the use of a novel cognitive enhancement strategy called Neuroflex to target CRCI experienced by breast cancer survivors.
The impact of cancer therapy on cognition in the elderly. [2021]Cancer and cancer therapy-related cognitive impairment (formerly known as chemobrain or chemo-fog) are often described in the literature. In the past, studies have failed to prove the existence of cancer therapy-related cognitive dysfunction. However, more recently, prospective trials have shown that patients undergoing chemotherapy do display impairment in specific cognitive domains. Aging confers an increased risk of developing cancer, as well as cognitive impairment. The Geriatric Oncology clinic of the Segal Cancer Centre, Jewish General Hospital in Montreal was founded in 2006 to address the unique needs of older cancer patients. We will describe two cases of cancer therapy-related cognitive impairment from our Geriatric Oncology clinic. The first case is that of a 75 year old male diagnosed with stage III non-small cell lung carcinoma who complained of forgetfulness since starting carboplatin-paclitaxel. The second case is that of a 65 year old female diagnosed with stage I, estrogen-receptor-positive breast cancer who had undergone lumpectomy followed by adjuvant cyclophosphamide, methotrexate and fluorouracil chemotherapy, radiation therapy and was on exemestane when she was evaluated. We will also briefly review the literature of cancer therapy-related cognitive impairment.
Chemotherapy-related cognitive impairment. [2022]Chemotherapy-related cognitive impairment (CRCI) was first described in the 1970s, but significant recognition of CRCI did not emerge with consistency until the late 1990s. Estimates of frequency now range from 17%-75%, and evidence suggests that CRCI, or "chemobrain" as it is referred to in the lay literature, is of significant concern to patients. A variety of potentially associated factors have been identified, including age, education level, intelligence, and social support; anxiety, depression, and fatigue; disease site, stage, and comorbidities; treatment regimen, timing, duration, and concomitant therapies; and hormonal levels, cytokine levels, damage to neural progenitor cells, and the presence of the apolipoprotein E 4 allele. Controversy exists as to the most suitable neurocognitive tests to evaluate this sequeal of treatment. Neuroimaging techniques are beginning to reveal affected areas of the brain. A neuropsychologist is essential for the assessment, diagnosis, and recommendation of appropriate management strategies for this patient population. Oncology nurses should be aware of available resources, such as relevant Web sites, support groups, neuropsychologists, and cognitive retraining programs, and provide support for patients concerned about or experiencing CRCI.