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Clinical Trial Summary

Breakthrough cancer pain (BTcP) is a rapid onset, high intensity and short duration pain episode, which takes place within a stable background pain control. It significantly affects the quality of life of oncologic patients and their ability to function normally. Rapid onset opioids are the standard treatment for BTcP, and the various fentanyl transmucosal formulations (FTF) are among the best examples of these treatments. However, the limited availability, the high cost, the complicated titration and the high risks of overdosing of FTF greatly challenge their use. In order to seek a potential alternative to FTF, the investigators are proposing to compare inhaled medical cannabis (PPP001) to FBT or placebo on relieving BTcP intensity in cancer patients.

Clinical Trial Description

This pilot study consists of two sub-studies:

1. An open-label randomized study to evaluate the effect of inhaled medical cannabis (PPP001) as compared to Fentanyl Buccal Tablets (FBT) to improve Pain Intensity (PI) in adult patients with breakthrough cancer pain (BTcP) and a stable opioid treatment for background pain:

After proper screening and verified inclusion criteria, 20 consecutive patients will be recruited to participate in this initial study. After baseline assessments, patients will be randomized to one of 2 parallel groups:

Group A: 10 patients will receive inhaled PPP001 for 2 weeks Group B: 10 patients will receive FBT for 2 weeks. During the first week of treatment, patients will be instructed to follow a specific titration regimen that will allow patients to optimize doses of PPP001 and FBT while adapting to the potential adverse events of both medications.

Next, there will be a washout period of 1 week and a cross over will occur. Therefore, Group B will receive PPP001 and Group A will receive FBT for other 2 weeks.

If the patient agrees and the physician investigator considers it is appropriate, a long-term follow-up of inhaled PPP001 for BTcP will be continued in an open-label fashion for the next 12 weeks.

2. A randomized double-blind placebo-controlled trial to evaluate the effect of inhaled PPP001 or FBT to improve PI when compared to placebo in another group of patients with BTcP:

After proper screening and verified inclusion criteria 40 consecutive patients will be recruited prospectively to participate in this trial. The same inclusion criteria of the open-label study will be applied with a different group of patients. After baseline assessments patients will be randomized to one of 2 parallel groups:

Group A: 4 weeks of PPP001 and fentanyl placebo buccal tablet (20 patients) Group B: 4 weeks of fentanyl buccal tablet and inhaled PPP001 placebo (20 patients) The inhalation of PPP001 or placebo will be allowed three times a day at 4-6 hours intervals. The use of previously prescribed rescue medication by treating physician will also be allowed. Patients will have a dose titration phase during the first week, followed by an additional 3-week period of treatment. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03564548
Study type Interventional
Source Tetra Bio-Pharma
Contact Cynthia El Hage, Ph.D
Phone (514) 419-4131
Status Not yet recruiting
Phase Phase 2
Start date December 1, 2018
Completion date June 30, 2019

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