Glioblastoma (GBM) is the most common malignant brain tumor among adults. 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 of which significantly impact their quality of life. Previous studies have demonstrated the potential of cannabinoids, particularly cannabidiol (CBD), to improve the aforementioned symptoms without conferring significant risks or side effects. Further, recent in-vitro and in-vivo work suggests potential cytotoxic and anti-tumor effects of CBD and other cannabinoids. This study includes a double-blind, placebo-controlled, 8-week randomized clinical trial assessing the impact of a custom formulated, full-spectrum, hemp-derived ultra-high CBD product on measures of anxiety, pain, and quality of life in newly-diagnosed GBM patients undergoing standard of care (SOC) treatment; the impact of this product vs. placebo on tumor progression will also be assessed. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
Custom-formulated full-spectrum solution high in cannabidiol
Placebo solution
University of California San Francisco Brain Tumor Center
San Francisco, California, United States
Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
The BAI is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 to 3 (higher scores indicating more anxiety). The full score range is 0-63.
Time frame: 8 weeks
Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a brief 5-item measure used to evaluate the functional impairment cause by anxiety; the frequency and intensity of anxiety, as well as the degree of avoidance and interference with work and social function are rated on a scale of 0 to 4. Total scores range from 0-20 (higher scores indicating more anxiety).
Time frame: 8 weeks
Change From Baseline in Pain Assessed by the Pain Distress Scale (PDS)
The PDS is an 11-point scale one where patients rate their pain by level of distress the pain causes on a scale of 0 to 10. Lower scores are better.
Time frame: 8 weeks
Change From Baseline in Pain Assessed by the Pain Disability Index (PDI)
On the PDI, the patient rates how their pain affects 7 different areas of their life on a scale of the level of disability that their pain causes, from "no disability" to "worst disability". The total score ranges from 0-70, with lower scores indicating less disability.
Time frame: 8 weeks
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI contains 19 self-rated questions that assess sleep quality and disturbance over the previous 1-month period. The 19 items yield seven component scores such as sleep latency, sleep duration, and daytime dysfunction, which are then summed to generate a global score from 0 to 21 (higher scores indicating lower sleep quality).
Time frame: 8 weeks
Patient's Global Impression of Change (PGIC) at Follow-Up
The PGIC is a single-question, 7-point scale (total score range: 1-7) depicting a patient's rating of overall improvement from "very much worse" to "very much improved", with higher scores indicating greater improvement.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.