Substance Related Disorders

Behaviors and Mental Disorders

All Conditions

Marijuana Abuse

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Anticonvulsants

All Drugs and Chemicals

Cannabidiol

This is a survey to determine the number of cancer pain patients who use and/or used Marijuana and/or CBD for pain or other symptom burdens.

The level of interest in learning more about cannabis for cancer pain, we can better facilitate a patient-centered approach to comprehensive treatment plans through patient education.

Cannabis (Marijuana)

The level of interest in learning more about cannabis for cancer pain, we can better facilitate a patient-centered approach to comprehensive treatment plans through patient education

Cannabidiol (CBD)

Salahadin Abdi, MD,PHD

To collect information about how patients in the pain management clinic use cannabis/CBD, including how often it is used, why it is used (for example, to manage pain or other symptoms), and where patients get their information on cannabis/CBD for pain management

Objectives

Primary Objective:

The primary objective of this study is to investigate the prevalence of current and prior cannabis and/or CBD use in cancer patients who present to the pain management clinic at MDACC.

Secondary Objectives:

The secondary objective is to investigate the reason for cannabis/CBD use (e.g. pain, neuropsychiatric symptoms, recreational or other use), degree of symptom improvement with use, frequency of use, methods of use (e.g. inhaled vs. ingested), sources of information on cannabis/CBD, and patient interest in learning more from their physicians about cannabis/CBD for cancer pain.

The Use of Cannabis (Marijuana) and Cannabidiol (CBD) Among Cancer Patients: A Pilot Study

Score scale ranges from 1-5, Extremely interested(1),Not Interested (5)

M.D. Anderson Cancer Center

Neoplasms

Rare Diseases

Anxiety Disorders

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Pharmaceutical Solutions

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

Custom-formulated full-spectrum solution high in cannabidiol

Placebo

Eduardo Rodriguez Almaraz, MD

Rosemary Smith, MS

Nicholas Butowski, MD

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.

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

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

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 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).

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.

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

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.

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.

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).

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.

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

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".

University of California, San Francisco

Center for Medicinal Cannabis Research

Mclean Hospital

Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core

Patients with confirmed solid cancer, after progression of all the available standard therapy or unfit to standard therapy according to oncologist's view, measurable disease as determined by RECIST using CT, life expectancy of at least 6 months, Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2 and aged 18 years old and more will be included in the current study.

Patients with confirmed solid cancer, after progression of all the available standard therapy or unfit to standard therapy according to oncologist's view, measurable disease as determined by RECIST using CT, life expectancy of at least 6 months, Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2 and aged 18 years old and more will be included in the current study

cannabidiol (CBD)

Yakir Rottenberg, MD MPH

Hadas Lemberg, PhD

Increasing lines of evidence support an antitumourigenic effect of cannabinoids, including the cannabidiol (CBD) which does not posses the psychotropic effects of D9-tetrahydrocannabinol (THC). These include anti-proliferative and pro-apoptotic effects and they are known to interfere with several mechanisms in the tumorgenesis. Yet, evidence from clinical trials among cancer patients is needed. The aim of the current study is to evaluate the impact of CBD as single treatment among cancer patients.

A Study: Pure CBD as Single-agent for Solid Tumor.

ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response or partial response (CR+PR) as assessed by investigatorand RECIST criteria.

Hadassah Medical Organization

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Arthralgia

Joint Diseases

Pain

Neurologic Manifestations

Aromatase Inhibitors

week 1: 25 mg twice daily, approximately 12 hours apart, with food

week 2: 50 mg twice daily, approximately 12 hours apart, with food

week 3: 75 mg twice daily, approximately 12 hours apart, with food

week 4+: 100 mg twice daily, approximately 12 hours apart, with food

Norah L Henry, MD, PhD

Study of Cannabidol to examine the safety and efficacy of 15 weeks of CBD in postmenopausal women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Investigators are looking to see if patients with joint pain see improvement with the use of CBD.

Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, absolute change for only one BPI item will be assessed, "joint pain and stiffness at its worst in the last week".

The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness at its worst in the last week", will be assessed.

The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness on the average", will be assessed.

The Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 (PROPr) is a validated questionnaire to assess patient-reported symptoms over the past 7 days in 7 PROMIS domains on a scale of 1 (worst) to 5 (best). Raw scores for each domain are calculated and then converted to a T-score, with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured: for fatigue, sleep disturbance, depression, and anxiety, higher scores represent worse symptoms; for physical functioning, ability to participate in social roles and activities, and cognitive function-abilities, higher scores mean better function.

Treatment related adverse events include those that are determined to be possibly, probably or definitely related to the study drug. Number of events will be reported by dose level and grade, per Common Terminology Criteria for Adverse Events (CTCAE) v.5.

The number of participants with undetectable levels of estradiol circulating in blood plasma will be reported at baseline and 15 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Use of Cannabis (Marijuana) and Cannabidiol (CBD) Among Cancer Patients: A Pilot Study	NCT05836857	Cancer	Cannabis (Marij... Cannabidiol (CB...	18 Years -	M.D. Anderson Cancer Center
A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients	NCT05753007	Glioblastoma	Cannabidiol (CB... Placebo	18 Years -	Mclean Hospital
A Study: Pure CBD as Single-agent for Solid Tumor.	NCT02255292	Solid Tumor	cannabidiol (CB...	18 Years -	Hadassah Medical Organization
A Study: Pure CBD as Single-agent for Solid Tumor.	NCT02255292	Solid Tumor	cannabidiol (CB...	18 Years -	Hadassah Medical Organization
The Use of Cannabis (Marijuana) and Cannabidiol (CBD) Among Cancer Patients: A Pilot Study	NCT05836857	Cancer	Cannabis (Marij... Cannabidiol (CB...	18 Years -	M.D. Anderson Cancer Center
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias	NCT04754399	Arthralgia Breast Cancer	Cannabidiol (CB...	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for cannabidiol (cbd)