Glioblastoma
Conditions
Brief summary
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.
Interventions
Custom-formulated full-spectrum solution high in cannabidiol
DRUGPlacebo
Placebo solution
Sponsors
Mclean Hospital
University of California, San Francisco
Center for Medicinal Cannabis Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documentation of newly diagnosed glioblastoma, evidenced by neuropathology report and based on World Health Organization (WHO) 2021 classification, and who are to undergo SOC (\~ 6 weeks of treatment) with radiation and temozolomide (patients using Optune may be included). * Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. * Fluent in English. * Endorses at least moderate levels of anxiety (on the BAI or OASIS) at the screening visit * Stable medication/psychotherapy regimens for at least 1 month prior to starting the study (excluding new glioblastoma treatment-related medications or radiation). * Karnofsky Performance Scale (KPS) of 60 or higher.
Exclusion criteria
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. * Presence of a condition or abnormality that in the opinion of the Investigators would compromise the safety of the patient or the quality of the data. * Current substance use disorder, psychotic disorder, bipolar disorder, or eating disorder. * Current use of recreational cannabis, medical cannabis, or hemp-derived cannabinoid products more frequently than 1x/month; positive urine delta-9 tetrahydrocannabinol (THC) test. * Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease. * Current use of valproate (due to potential for drug-drug interactions). * Currently enrolled in other research studies or clinical trials involving therapeutic interventions. * Subjects with serum transaminase (ALT, AST, and total bilirubin) levels \>3 times upper limit of normal (UNL) \<24 hours prior to day 1 of treatment. * Contraindication to MRI such as non-MR conditional medical devices or ferrous retained foreign bodies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) | 8 weeks | 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. |
| Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS) | 8 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Assessed by the Pain Distress Scale (PDS) | 8 weeks | 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. |
| Change From Baseline in Pain Assessed by the Pain Disability Index (PDI) | 8 weeks | 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. |
| Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI) | 8 weeks | 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). |
| Patient's Global Impression of Change (PGIC) at Follow-Up | 8 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Patients were randomized following the baseline visit, once eligibility was determined.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Karnofsky Performance Status (KPS) | 90 Score |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
None listed