NCT04001010

Safety and Efficacy of Inhaled Synthetic THC/CBD for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia

Safety and Efficacy of PPP011-kit for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia: a Randomized, Double Blind, Placebo Controlled, Parallel Group Study

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: Tetra Bio-Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A large number of patients with advanced cancer also suffer from cachexia. Cachexia is a syndrome characterized by loss of skeletal muscle mass (with/or without loss of fat mass) that cannot be reversed by nutritional support and progressively leads to functional impairment. Patients who suffer from anorexia and cachexia have lower survival rates. Some patients with cancer use cannabis to improve the way they feel and relieve their pain. However, there is very sparse high-quality research to prove that cannabis products are truly effective. This study will investigate patients with advanced cancer who use inhaled therapeutic cannabinoid-based medication (PPP011), in addition to palliative care management, and will assess if these patients experience improvement in functional status as a surrogate endpoint for survivalquality

Detailed description

This is a 12-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP011 on physical functioning and cachexia progression in patients with cachexia related to advanced incurable cancer.

Conditions

• Cannabis Use
• Cachexia; Cancer
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	PPP011	1 capsule inhaled 3 times a day with a vaporizer device
DRUG	Placebo	1 capsule inhaled 3 times a day with a vaporizer device

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2019-06-27
• Last updated: 2021-02-05

Locations

1 site across 1 country: Canada