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Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial

ConditionsBreast CancerSarcomaGastric CancerLung CancerHead and Neck CancerColorectal CancerOvarian CancerLiver CancerGenitourinary CancerGynecologic CancerUrinary Bladder CancerLeukemiaLymphoid LeukemiaMyeloma MultipleProstate CancerPancreas CancerNon-hodgkin LymphomaHodgkin LymphomaBrain CancerMelanomaMycosis FungoidesKidney Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cohort-specific inclusion for male and female patients.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Riluzole

    Drug

    Given PO

  • Placebo

    Drug

    Given PO

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: RiluzoleExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study.

Time frame
8 weeks

Secondary outcomes

1

Cognitive Function Scores (FACT-Cog)

Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) scores, including both cumulative and perceived cognitive impairment scores. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes.There are four other scoring subscales in FACT-Cog v3: perceived cognitive impairments (PCI; 18 items); perceived cognitive abilities (7 items); impact of perceived cognitive impairment on QOL (4 items); and comments from others on cognitive function (4 items). Both total and PCI scores will be calculated in this study. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning. Similarly, PCI score is calculated by summing responses of all relevant items and ranges from 0 to 72.

Time frame
8 weeks
2

Cognitive Function Scores (CANTAB)

The study will assess the effects of riluzole on cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB) scores across five cognitive domains. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes. Cognitive domains of response speed, learning and memory, working memory, multitasking, and sustained attention will be assessed with CANTAB®. Using International Cognition and Cancer Task Force (ICCTF criteria), overall cognitive impairment is defined as ≥ 2 standard deviations below normative mean on at least 1 cognitive test or ≥ 1.5 standard deviations below normative mean on 2 or more tests.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Source ClinicalTrials.gov
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