Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer

Study Overview
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Brief Summary
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This phase 2 multicenter clinical trial assess the safety and efficacy of inhaled PPP001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 1 year.

Detailed Description
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This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 on uncontrolled cancer pain in patients with symptoms related to advanced incurable cancer.

Official Title
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SAFETY AND EFFICACY OF PPP001-kit FOR THE UNCONTROLLED PAIN RELIEF IN PATIENTS WITH ADVANCED CANCER: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY

Conditions
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Cancer Pain, Quality of Life, Pain, Acute, Cannabis Use

Intervention / Treatment
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* Drug: PPP001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent, Adult male and female patients at least 18 years of age, Subject agreed to follow the protocol, Advanced cancer for which there is no known curative therapy as per investigator's judgement, Patients experiencing at least 2 symptoms related to cancer > 4 on ESAS-r-CS NRS including pain symptom, Life expectancy six weeks or longer with PPS > 50% and PaP Score Group A (30-day survival probability >70%), No cognitive impairment according to Mini-Cog©, The patient is able to perform deep inhalations with FEV1 more than 60%, Ability to read and respond to questions in English, A female volunteer must meet one of the following criteria: If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose, If of non-childbearing potential - should be surgically sterile or in a menopausal state, A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled THC/CBD (PPP001)<br>PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device | Drug: PPP001<br>* 1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device<br>* Other names: QIXLEEF;|
| Placebo Comparator: Placebo<br>Placebo inhalation with a device | Drug: Placebo<br>* 1 placebo dosing capsule inhaled 3 times a day with a vaporizer device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncontrolled cancer pain will be measured using a patient self-administered questionnaire. | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). items are rated on a scale of 1 (not at all) to 4 (very much). high scores on a symptom scale correlate to increased symptom burden | change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall HRQoL (Health related Quality of Life) of patients with uncontrolled symptoms related to advanced cancer will be measured using a patient self rating questionnaire. | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). single-item scale is rated from 1 (very poor) to 7 (excellent). High scores on a functional scale correspond to better functioning | change from baseline in the EORTC-QLQ-C15-PAL overall QoL single-item scale score at Week 4 | 
| The physical, emotional, and total symptom distress will be measured using a patient self administered questionnaire. | Revised Edmonton Symptom Assessment System (ESAS-r-CS). 11 core symptoms: pain, tiredness, nausea, depression, anxious, drowsiness, appetite, feeling of well-being, shortness of breath, constipation and trouble sleeping. 11-point NRS ranging from 0 (no symptom) to 10 (worst possible). | Change from Baseline in ESAS-r-CS at Weeks 1 and 4 | 
| The palliative performance scale will be scored by a healthcare profesional. | palliative performance scale version 2 (PPSv2) for measuring functional status in end-of-life patients. A healthcare professional scores each dimension by assigning a value from 100% to 0% (death), with 10% denoting the lowest level of functioning | Change from Baseline in PPS at Weeks 1 and 4 | 
| The satisfaction of family caregivers of patients with advanced cancer will be measured using a caregiver self administered questionnaire. | The treatment satisfaction questionnaire (change version) will be used. Scale range is a left to right 7-item scale for caregiver. each item is scored from 5 (Much more satisfied now) to 1 (Much Less satisfied now). | Change from Baseline in treatment-satisfaction questionnaire at Weeks 1 and 4 | 
| The distress of patients with advanced cancer will be measured using a patient self-administered questionnaire | distress thermometer adopted as a screening measure to identify and address psychological distress in individuals with cancer. Results support a cut-off score of 3 on the DT to indicate patients with clinically elevated levels of distress . | Change from Baseline in distress thermometer at Week 4 |