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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: 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

Study ID: NCT04001010

Interventions

PPP011
Placebo

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

William Osler Health Service Brampton, Brampton, Ontario, Canada

Contact Details

Name: Martin Chasen, MD

Affiliation: William Osler Health Service Brampton

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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