Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05753007
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-02-10
Brief Title:
A Clinical Trial of a Hemp-Derived High Cannabidiol Product for Anxiety in Glioblastoma Patients
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
A Randomized Double-blind Clinical Trial of a Hemp-Derived High Cannabidiol Product for Anxiety in Glioblastoma Patients
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None