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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2022-09-30

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.

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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.

Conditions

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Cancer Pain Quality of Life Pain, Acute Cannabis Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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inhaled THC/CBD (PPP001)

PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device

Group Type EXPERIMENTAL

PPP001

Intervention Type DRUG

1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device

Placebo

Placebo inhalation with a device

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 placebo dosing capsule inhaled 3 times a day with a vaporizer device

Interventions

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PPP001

1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device

Intervention Type DRUG

Placebo

1 placebo dosing capsule inhaled 3 times a day with a vaporizer device

Intervention Type DRUG

Other Intervention Names

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QIXLEEF

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No