Clinical trial NCT04042545: Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer Pain
Quality of Life
Pain, Acute
Cannabis Use
Lead sponsor: Tetra Bio-Pharma
Sponsor class: INDUSTRY
First posted: 2019-08-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent,
2. Adult male and female patients at least 18 years of age,
3. Subject agreed to follow the protocol,
4. Advanced cancer for which there is no known curative therapy as per investigator's judgement,
5. Patients experiencing at least 2 symptoms related to cancer \> 4 on ESAS-r-CS NRS including pain symptom,
6. Life expectancy six weeks or longer with PPS \> 50% and PaP Score Group A (30-day survival probability \>70%),
7. No cognitive impairment according to Mini-Cog©,
8. The patient is able to perform deep inhalations with FEV1 more than 60%,
9. Ability to read and respond to questions in English,
10. 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,
11. 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.

Primary outcomes:
measure: Uncontrolled cancer pain will be measured using a patient self-administered questionnaire.
timeFrame: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4.
Secondary outcomes:
measure: 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.
timeFrame: change from baseline in the EORTC-QLQ-C15-PAL overall QoL single-item scale score at Week 4
measure: The physical, emotional, and total symptom distress will be measured using a patient self administered questionnaire.
timeFrame: Change from Baseline in ESAS-r-CS at Weeks 1 and 4
measure: The palliative performance scale will be scored by a healthcare profesional.
timeFrame: Change from Baseline in PPS at Weeks 1 and 4
measure: The satisfaction of family caregivers of patients with advanced cancer will be measured using a caregiver self administered questionnaire.
timeFrame: Change from Baseline in treatment-satisfaction questionnaire at Weeks 1 and 4
measure: The distress of patients with advanced cancer will be measured using a patient self-administered questionnaire
timeFrame: Change from Baseline in distress thermometer at Week 4
Other outcomes:
Locations:
city: Cave Creek
country: United States
facility: Scottsdale Research Institute
state: Arizona
Study officials:
References: