Brain Cancer, Breast Cancer, Colorectal Cancer, Gastric Cancer, Genitourinary Cancer, Gynecologic Cancer, Head and Neck Cancer, Hodgkin Lymphoma, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Lymphoid Leukemia, Melanoma, Mycosis Fungoides, Myeloma Multiple, Non-hodgkin Lymphoma, Ovarian Cancer, Pancreas Cancer, Prostate Cancer, Sarcoma, Urinary Bladder Cancer
Conditions
Brief summary
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.
Interventions
DRUGRiluzole
Given PO
DRUGPlacebo
Given PO
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Cohort-specific inclusion for male and female patients. a. Cohort A (no prior cranial radiation) i. Diagnosed with one of the following: * 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. b. Cohort B (prior cranial radiation) * Previously received radiotherapy or radiosurgery to the brain for benign, malignant, or metastatic tumors. * Life expectancy \> 6 months 2. Washout from investigational and conventional interventions is up to the discretion of the investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study. 3. ≥18 years of age 4. Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or cancer treatment. 5. Able to provide informed consent. 6. Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires. 7. 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.
Exclusion criteria
1. Cohort-specific exclusion for male and female patients: 1. Cohort A (no prior cranial radiation) * History of or current presence of primary brain tumors or brain metastases. 2. Cohort B (prior cranial radiation) * Diagnosed with high grade glioma. 2. Unwilling to undergo neuropsychological assessments necessary for the study. 3. Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Persons of child-bearing potential (POCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy. a. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy. 4. History of suspected hypersensitivity to riluzole or to any of its excipients. 5. Patients taking or planned to take medications/substances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole. 6. Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN) 7. Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI) | 8 weeks | Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function Scores (FACT-Cog) | 8 weeks | 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. |
| Cognitive Function Scores (CANTAB) | 8 weeks | 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. |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORAlexandre Chan, PharmD, MPH
Chao Family Comprehensive Cancer Center
Outcome results
None listed