Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT03763851
Status:
TERMINATED
Last Update Posted:
2020-03-12
First Post:
2018-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cannabis Oil and Radiation Therapy for the Management of Pain
Sponsor:
Tetra Bio-Pharma
Organization:
Study Overview
Official Title:
Cannabis Oil and Radiation Therapy for the Management of Pain: Assessment of Safety and Efficacy in a Randomized, Double-blind Placebo-controlled Phase II/III Clinical Trial
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to mycotoxin potential contamination of one lot of study drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this innovative approach seeking effective therapeutic strategies, the investigators are proposing to test the effectiveness of medical cannabis oil as an adjunct to palliative Radiation Therapy (RT) and Best Supportive Care to alleviate cancer pain that was only partially relieved with conventional medications. Furthermore, the investigators will assess the effect of medical cannabis oil on health-related quality of life and symptoms that are frequently associated with metastatic cancers including fatigue, anxiety, depression, insomnia and decreased appetite. The safety profile of medical cannabis oil with respect to prolonged use of more than two weeks of administration, concomitant medication use and palliative RT will also be examined.
Detailed Description:
This is a 6-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open-label extension phase of 12 weeks, to evaluate tolerability of medical cannabis oil to reduce chronic pain intensity.
Consecutive adult patients between the ages of 18 and 75, male and female, with cancer pain, with an average weekly pain intensity score greater than 4 on the 11 points Numerical Rate Scale (NRS), will be prospectively recruited and invited to participate in this trial.
Informed consent will be obtained by a Research Assistant.
After baseline documentation with standardized scales, patients will be randomized to one of two parallel groups:
* Cannabis group: Delta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule
* Placebo group: Placebo capsule
* All patients will receive palliative RT to the symptomatic site. Patients will have a dose titration phase during the first week. The dose escalation will allow patients to adapt to the potential adverse effects (AEs) of the medical cannabis.
Follow-up visits either in person or by phone will be at 1 week, 3 weeks and 6 weeks of treatment.
At the end of the first phase of the study, patients who wish to participate in the open-label extension phase will have the option to continue in the same treatment regimen. For the placebo group, patients will have the option to receive the active treatment during the 12-week open-label phase if the study physician feels it may potentially provide benefits. Similarly, the dose will be titrated up in the placebo group who wants to receive the active drug in the extension program.
The open-label phase is 12 weeks long. For this open-label extension phase the follow-up visits will be done after 4 weeks and 12 weeks of treatment.
Consecutive adult patients between the ages of 18 and 75, male and female, with cancer pain, with an average weekly pain intensity score greater than 4 on the 11 points Numerical Rate Scale (NRS), will be prospectively recruited and invited to participate in this trial.
Informed consent will be obtained by a Research Assistant.
After baseline documentation with standardized scales, patients will be randomized to one of two parallel groups:
* Cannabis group: Delta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule
* Placebo group: Placebo capsule
* All patients will receive palliative RT to the symptomatic site. Patients will have a dose titration phase during the first week. The dose escalation will allow patients to adapt to the potential adverse effects (AEs) of the medical cannabis.
Follow-up visits either in person or by phone will be at 1 week, 3 weeks and 6 weeks of treatment.
At the end of the first phase of the study, patients who wish to participate in the open-label extension phase will have the option to continue in the same treatment regimen. For the placebo group, patients will have the option to receive the active treatment during the 12-week open-label phase if the study physician feels it may potentially provide benefits. Similarly, the dose will be titrated up in the placebo group who wants to receive the active drug in the extension program.
The open-label phase is 12 weeks long. For this open-label extension phase the follow-up visits will be done after 4 weeks and 12 weeks of treatment.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: