NCT06533657

Unique Treatment of Oncology Pain in Advanced Cancer

A Phase 2A Study to Investigate the Safety and Preliminary Analgesic Efficacy of Oral Trichomylin® in Male and Female Participants 18 Years of Age and Above With Advanced Cancer and Moderate to Severe Cancer-Related Pain

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: ZYUS Life Sciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a proof-of-concept, single arm study with a maximum of 20 patients to evaluate preliminary analgesic efficacy and safety of Trichomylin® in patients with advanced cancer (male and female) who suffer from moderate to severe chronic pain and who are taking a stable dose of long-acting opioid therapy for at least 1 week prior to screening.

Detailed description

This study will consist of a screening visit, treatment, and safety follow-up period. There will be an initial patient determined titration phase, using escalated doses of Investigational Product, to reach a dose that achieves symptom relief with tolerable side effects. Each capsule of Trichomylin® contains a fixed ratio of 5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene. Participants can titrate up to a maximum of 2 capsules twice daily (total of 4 capsules). This will be followed by a 5 day assessment period of the stable dose determined in collaboration with clinicians.

Conditions

• Cancer Pain

Interventions

Type	Name	Description
DRUG	Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)	Cancer patients meeting eligibility criteria will receive Trichomylin® and self-titrate to effective dose.

Timeline

• Start date: 2025-06-12
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-08-01
• Last updated: 2026-03-12

Locations

3 sites across 1 country: Canada