A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cannabidiol (CBD)

Placebo

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of California San Francisco Brain Tumor Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cannabidiol (CBD) Solution Plus Standard of Care (SOC)

Placebo

Arm Description

Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment

Placebo solution administered for 8 weeks along with standard of care treatment

Outcomes

Primary Outcome Measures

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).

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 (higher scores indicating more anxiety).

Secondary Outcome Measures

Change from Baseline in Pain Assessed by the Brief Pain Inventory (BPI)

The BPI contains 9 questions that assess the severity of pain, how much relief is provided by treatment, and the functional impact of the pain within the last 24 hours. Lower scores are better.

Change from Baseline in Pain Assessed by a Visual Analog Scale (VAS)

The VAS is a 100mm line where patients draw a vertical line to indicate their pain level from 0-100. Lower scores are better.

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.

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". Lower scores are better.

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 (higher scores indicating decreased sleep quality).

Change from Baseline in Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

The EORTC QLQ-C30 contains 30 questions assessing a cancer patient's quality of life. Lower scores indicate better quality of life and fewer symptoms.

Change from Baseline in Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20

The EORTC QLQ-BN20 module contains 20 additional questions specifically for brain tumor patients. Lower scores indicate better quality of life and fewer symptoms.

Patient's Global Impression of Change (PGIC) at Follow-Up

The PGIC is a single-question, 7-point scale depicting a patient's rating of overall improvement from "very much worse" to "very much improved".

Full Information

NCT ID

NCT05753007

First Posted

February 10, 2023

Last Updated

August 30, 2023

Sponsor

Mclean Hospital

Collaborators

University of California, San Francisco, Center for Medicinal Cannabis Research

1. Study Identification

Unique Protocol Identification Number

NCT05753007

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

September 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mclean Hospital

Collaborators

University of California, San Francisco, Center for Medicinal Cannabis Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cannabidiol (CBD) Solution Plus Standard of Care (SOC)

Arm Type

Experimental

Arm Description

Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo solution administered for 8 weeks along with standard of care treatment

Intervention Type

Drug

Intervention Name(s)

Cannabidiol (CBD)

Intervention Description

Custom-formulated full-spectrum solution high in cannabidiol

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo solution

Primary Outcome Measure Information:

Title

Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)

Description

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).

Time Frame

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Title

Change from Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)

Description

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 (higher scores indicating more anxiety).

Time Frame

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Secondary Outcome Measure Information:

Title

Change from Baseline in Pain Assessed by the Brief Pain Inventory (BPI)

Description

The BPI contains 9 questions that assess the severity of pain, how much relief is provided by treatment, and the functional impact of the pain within the last 24 hours. Lower scores are better.

Time Frame

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Title

Change from Baseline in Pain Assessed by a Visual Analog Scale (VAS)

Description

The VAS is a 100mm line where patients draw a vertical line to indicate their pain level from 0-100. Lower scores are better.

Time Frame

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Title

Change from Baseline in Pain Assessed by the Pain Distress Scale (PDS)

Description

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

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Title

Change from Baseline in Pain Assessed by the Pain Disability Index (PDI)

Description

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". Lower scores are better.

Time Frame

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Title

Change from Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

Description

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 (higher scores indicating decreased sleep quality).

Time Frame

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Title

Change from Baseline in Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

Description

The EORTC QLQ-C30 contains 30 questions assessing a cancer patient's quality of life. Lower scores indicate better quality of life and fewer symptoms.

Time Frame

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Title

Change from Baseline in Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20

Description

The EORTC QLQ-BN20 module contains 20 additional questions specifically for brain tumor patients. Lower scores indicate better quality of life and fewer symptoms.

Time Frame

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Title

Patient's Global Impression of Change (PGIC) at Follow-Up

Description

The PGIC is a single-question, 7-point scale depicting a patient's rating of overall improvement from "very much worse" to "very much improved".

Time Frame

1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eduardo Rodriguez Almaraz, MD

Phone

415-353-2966

Email

eduardo.rodriguez@ucsf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Rosemary Smith, BS

Phone

617-855-2908

Email

rsmith@mclean.harvard.edu

Facility Information:

Facility Name

University of California San Francisco Brain Tumor Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eduardo Rodriguez Almaraz, MD

Phone

415-353-2966

Email

eduardo.rodriguez@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Nicholas Butowski, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Glioblastoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial