Inhaled Cannabis Versus Fentanyl Buccal Tablets for Management of Breakthrough Pain in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03564548|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Breakthrough Cancer Pain||Combination Product: PPP001 Drug: FBT Combination Product: Active PPP001 with FBT Placebo Drug: Active FBT with PPP001 Placebo||Phase 2|
This pilot study consists of two sub-studies:
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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The first part of the study will be in a crossover model and the second part in a parallel model|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Inhaled PPP001 Versus Buccal Tablets for the Management of Breakthrough Pain in Caner Patients: an Open Label, Crossover, Comparison Study Followed by a Randomized, Double-blind, Placebo-controlled Pilot Trial|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: Inhaled medical cannabis (PPP001)
280 mg dried cannabis pellet -(9% THC / 2% CBD per pellet)
THC: Δ-9-tetrahydrocannabinol CBD: Cannabidiol
Combination Product: PPP001
Group assigned to PPP001 during the open-label
Active Comparator: Fentora Buccal Tablets (FBT)
Fentora Buccal Product are composed of a potent opioid analgesic, intended for buccal mucosal administration. The tablets contain fentanyl citrate equivalent to fentanyl base and will be given in low-dose (100 mcg) or high-dose (200 mcg).
Group assigned to FBT during the open-label
Other Name: Fentora Buccal tablets
Experimental: Active PPP001 with FBT Placebo
Fentanyl Placebo tablets will have no fentanyl and will look identical to the active FBT. For these tablets there will also be low-dose tablets and high-dose tablets which will look identical to the active FBT 100 mcg and 200 mcg tablets.
Combination Product: Active PPP001 with FBT Placebo
Group assigned to active PPP001 in the randomized placebo-controlled trial
Other Name: Active PPP001 with Fentora Buccal tablets Placebo
Active Comparator: Active FBT with PPP001 Placebo
The placebo is designed to contain 0% Δ-9-tetrahydrocannabinol (THC) and as per the placebo specifications < 0.9% total Cannabidiol (CBD).
Drug: Active FBT with PPP001 Placebo
Group assigned to active FBT in the randomized placebo-controlled trial
Other Name: Active Fentora Buccal tablets with PPP001 Placebo
- Breakthrough cancer pain intensity assessed by Pain Intensity (PI) measurement a numerical rating scale [ Time Frame: Changes from baseline PI at 60 minutes post PPP001 or FBT administration ]
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
- Patient's general impression (GI) of drug efficacy assessed by a verbal rating scale [ Time Frame: GI of drug efficacy will be measured at 60 minutes following the administration of PPP001 or FBT ]The patient's general impression (GI) of drug efficacy will be measured using a 5-point verbal rating scale ranging from 0=poor to 4=excellent
- Cognition improvement assessed by Mini-Cog, a screening tool for Cognition [ Time Frame: Mini-Cog used at baseline, at week 2 and week 5 of the open-label, crossover comparison study and at week 1 and week 4 follow-up of the randomized placebo-controlled trial ]Using the Mini-Cog, a simple and effective instrument with excellent screening characteristics, that compared to other cognitive tools, takes less time to be performed. This test consists of a delayed three-word recall (0-3 points) and a clock drawing test (0-2 points). It was developed for the community care setting, takes three to five minutes to complete, and education or language do not seem to importantly influence test results. A cut point of < 4 points will suggest cognitive impairment in this population
- Mood improvement assessed by the Profile of Mood States [ Time Frame: Both questionnaires will be done at baseline, at week 2 and week 5 of the open-label, crossover comparison study and at week 1 and week 4 follow-up of the randomized placebo-controlled trial ]Using the Profile of Mood States (POMS), which is a self-administered questionnaire designed to assess current mood states through six bipolar scales: elated/depressed, composed/anxious, energetic/tired, agreeable/hostile, confident/unsure, and clear-headed/confused.
- Quality of life improvement assessed by the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire (QLQ-C30) [ Time Frame: This will be performed at baseline, at week 2 and week 5 of the open-label, crossover comparison study and at week 1 and week 4 follow-up of the randomized placebo-controlled trial. ]
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for cancer (QLQ-C30). This is a 30-item core-cancer specific questionnaire integrating system for assessing Health Related quality of Life (HRQoL) of cancer patients participating in international clinical trials. The questionnaire incorporates five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), a global health and QOL scale, and single items for the assessment of additional symptoms commonly reported by cancer patients (e.g., dyspnea, insomnia, appetite loss, constipation, and diarrhea), as well as the perceived financial impact of the disease and treatment.
All items are scored on 4-point Likert scales, ranging from 1 ("not at all") to 4 ("very much"), with the exception of two items in the global health/ QOL scale which use modified 7-point linear analog scales
- Effects of PPP001 on concurrent medications compliance [ Time Frame: This will be done at baseline, at week 2 and week 5 of the open-label, crossover comparison study and at week 1 and week 4 follow-up of the randomized placebo-controlled trial. ]Changes in concurrent medications will be measured using the Medication Quantification Scale (MQS) version III. The MQS version III is a method of quantifying different pain drug regimens by evaluating the use of 22 distinct drug classes (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], antidepressants, benzodiazepines, opiates). A single value is calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed.
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): NCT03564548
|Contact: Cynthia El Hage, Ph.D||(514) 419-4131 ext firstname.lastname@example.org|
|Contact: Guy Chamberland, MSc, PhDemail@example.com|
|Montréal, Quebec, Canada, H2L 3K9|
|Principal Investigator:||Antonio Vigano, MD, MSc||McGill University|
|Study Director:||Erin Prosk, MSc||Santé Cannabis|