Clinical Trials Logo

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
Email cynthia.el.hage@tetrabiopharma.com
Status Not yet recruiting
Phase Phase 2
Start date September 1, 2018
Completion date March 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Active, not recruiting NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
Completed NCT01340846 - A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors Phase 1
Recruiting NCT02565004 - Clinical and Laboratory Analysis of Familial Cancer
Active, not recruiting NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center N/A
Recruiting NCT03684005 - MyPatientPal: An App to Help Patients Manage Their Cancer Care N/A
Not yet recruiting NCT03662061 - Assessment of a Multidisciplinary Team Meeting (RCP) in Geriatric Oncology
Recruiting NCT03247309 - TCR-engineered T Cells in Solid Tumors With Emphasis on NSCLC and HNSCC (ACTengine) Phase 1
Completed NCT03272880 - Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers N/A
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer N/A
Active, not recruiting NCT03548077 - POWERPLAY: Promoting Men's Health at Work N/A
Completed NCT03503838 - A Pilot Study of Online Yoga for MPN Patients N/A
Completed NCT00984035 - Investigation of Cisplatin-Related Kidney Toxicity
Completed NCT01447186 - Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men N/A
Recruiting NCT03463941 - Peer Support Dyads in Churches N/A