INVESTIGATOR: Nicholas Butowski, M.D. & Staci Gruber, Ph.D.

STUDY LOCATION: University of California, San Francisco

PROJECT TITLE: A clinical trial of a hemp-derived, ultra-high cannabidiol product for anxiety and pain in glioblastoma patients

FUNDING SOURCE: Center for Medicinal Cannabis Research

PROJECT TYPE: Clinical Study

STATUS: Active (Enrolling)

ABSTRACT:

Glioblastoma (GBM) is the most common malignant brain tumor among adults and is incurable with a very low estimated 5-year survival rate. As the diagnosis is generally considered terminal, patients with GBM often suffer from anxiety and other comorbid conditions, including depression, pain, and sleep disturbance, all which significantly impact their quality of life. Importantly, data suggest higher levels of anxiety and depression are associated with poorer prognoses. Previous studies have demonstrated the potential of cannabinoids, particularly cannabidiol (CBD), to vastly improve the aforementioned symptoms without conferring significant risks or side effects. Further, recent in-vitro and in-vivo work suggests potential cytotoxic and antitumor effects of CBD and other cannabinoids. Accordingly, we propose a novel, double-blind, placebo-controlled, 8-week randomized clinical trial assessing the impact of a custom formulated, full-spectrum, hemp-derived ultra-high CBD product (IND received) on measures of anxiety and quality of life in newly-diagnosed GBM patients undergoing standard of care (SOC) treatment; we will also quantify the impact of this product vs. placebo on tumor progression. We hypothesize that GBM patients treated with the study product (N=24) will experience a reduction in selfreported ratings of anxiety and concurrent improvement on quality-of-life measures compared to a control group receiving SOC and placebo (N=12). We also hypothesize that patients receiving study product will demonstrate slower tumor progression and/or greater imaging stability compared to the placebo group. Outcome variables will be evaluated using a mixed-effects multivariate regression model to determine significance of change in self-reported ratings and markers of tumor progression. The study product contains a range of cannabinoids and terpenoids, likely to prove beneficial for palliative care in treating symptoms and improving overall quality of life and may in fact slow or halt disease progression in patients with GBM. The proposed clinical trial will provide important information that does not currently exist regarding the potential efficacy of a novel full-spectrum, ultra-high CBD product to address clinical symptoms in patients with GBM. This study will pave the way for future investigations to explore new options for treating clinical manifestations of this deadly disease, and presents an exciting, new approach for potentially slowing or halting disease progression in this population.