Clinical trial NCT05753007: A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients
Official title: A Randomized, Double-blind, Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Glioblastoma
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Center for Medicinal Cannabis Research
First posted: 2023-03-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: Change from Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary outcomes:
measure: Change from Baseline in Pain Assessed by the Brief Pain Inventory (BPI)
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: Change from Baseline in Pain Assessed by a Visual Analog Scale (VAS)
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: Change from Baseline in Pain Assessed by the Pain Distress Scale (PDS)
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: Change from Baseline in Pain Assessed by the Pain Disability Index (PDI)
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: Change from Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: Change from Baseline in Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: Change from Baseline in Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: Patient's Global Impression of Change (PGIC) at Follow-Up
timeFrame: 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Brain Tumor Center
state: California
Study officials:
References: