drugset / Trial / 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

NCT04001010 ↗

Phase 3 Suspended 334 enrolled Tetra Bio-Pharma
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2022-07
Primary completion
2023-07
Completion
2023-12

Outcome

Outcome not reported

Stopped: “Study is postponed”

Drugs

EvaluationDrugModalityDoseRoute
Subject PPP011 Unknown — Inhaled