Cannabis Oil and Radiation Therapy for the Management of Pain
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|ClinicalTrials.gov Identifier: NCT03763851|
Recruitment Status : Terminated (due to mycotoxin potential contamination of one lot of study drug)
First Posted : December 4, 2018
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Cancer Lung Cancer Breast Cancer||Radiation: Active PPP005 Radiation: Radiotherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||March 14, 2018|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||November 30, 2018|
Experimental: Cannabis group
Delta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule
These capsules contain different cannabis formulations with low-dose and high-dose preparations according to the treatment group:
Radiation: Active PPP005
Group assigned to active PPP005 in the randomized placebo-controlled trial
Palliative RadioTherapy to the symptomatic site
Placebo Comparator: Placebo group
The placebo capsule will have no cannabis, it will look identical to the active treatment capsule, and it will also be prepared in "low-dose" and "high-dose" presentations.
Palliative RadioTherapy to the symptomatic site
- Cancer pain intensity assessed by Pain Intensity (PI) measurement a numerical rating scale [ Time Frame: Change (a reduction of 30% in pain intensity) in pain intensity after medical cannabis oil administration compared to placebo at 6 weeks compared to baseline ]
Pain Intensity (PI) measurement a Numerical Rating Scale (zero= no pain and 10= pain as bad as it can be).
A reduction of PI ≥ 33% will be considered as a clinically important level of pain relief
- Cancer pain quality using the Brief Pain Inventory-SF (BPI-SF) [ Time Frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment ]The BPI-SF consists of nine questions; eight have a single response, and Question 9 is subdivided into seven parts. The Total BPI for Question 9 is the unweighted sum of the seven assessments and represents the effect of pain
- Impact of medical cannabis oil combined with radiation treatment on HRQoL as measured by the EQ-5D-5L [ Time Frame: at baseline, 1-week, 3-week, and 6-week follow-up ]
- Functional status assessed by the Functional Assessment of Cancer Therapy for Prostate patients (FACT-P). [ Time Frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment ]
- Fatigue burden assessed by the Brief Fatigue Inventory (BFI). [ Time Frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment ]
- Cognitive status assessed by the Mini-Cog [ Time Frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763851
|Montreal, Quebec, Canada|
|Principal Investigator:||Tamim Niazi, MD||Jewish General Hospital, McGill University|
|Principal Investigator:||Jean Zigby, MD||Jewish General Hospital, McGill University|