Unique Treatment of Oncology Pain in Advanced Cancer

NCT06533657 | Completed Phase 2 DMC

• 1 other identifier: Z-TRI-10002A
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cancer Pain

Keywords

Cannabinoid; Safety and Tolerability; Preliminary Efficacy; Opioid-sparing

Outcome Measures

Primary Outcomes (7)

• Number of Participants That Reach the Stable Dose during Dose Titration

  Investigational Product will be titrated up incrementally until participants achieve their "optimal dose" that achieves symptom relief with tolerable side effects or to a maximum of 2 capsules twice daily. Once participants have had 2 full days (at minimum) of treatment at this dosage, this will then be considered their "stable dose".

  Baseline (i.e. Day 1 Dose Titration) and Stable Dose Day 1, up to 14 days

• Change in Average Pain Scores from Baseline to Investigational Product Discontinuation

  The Brief Pain Inventory Short Form (BPI-SF) is a standardized scale used for capturing participant reported symptom assessments related to pain severity and the resulting functional interference caused by pain. The BPI-SF has a numerical rating scale used by participants to indicate their level of pain. Participants are asked to assign a number that best describes their pain on average from 0 = no pain, to 10 = pain as bad as you can imagine, at the same time every day during the Screening period (Day -7 to Day -1) and enter this number in response to the BPI-SF Question #5 on the evaluation form.

  Baseline and Investigational Product Discontinuation, up to 23 days

• Proportion of Responders to Average Pain from Baseline to Investigational Product Discontinuation

  Average pain as entered in response to the BPI-SF Question #5, where response is defined as having a baseline of ≥30% from baseline at the Investigational Product discontinuation visit.

  Baseline and Investigational Product Discontinuation, up to 23 days

• Number of Participants That Reach the Stable Dose during Dose Titration and Respond to Average Pain from Baseline to Investigational Product Discontinuation

  Participants have reached their "stable dose" and respond to average pain as entered in response to the BPI-SF Question #5, where response is defined as having a baseline of ≥30% from baseline at the Investigational Product discontinuation visit.

  Baseline and Investigational Product Discontinuation, up to 23 days

• Change in Average Pain from Baseline to End of the Titration

  Average pain as entered in response to the BPI-SF Question #5.

  Baseline and End of Dose Titration, up to 14 days

• Change in Pain Interference from Baseline to End of the Titration

  Pain interference is scored as the mean of the seven interference items and entered in response to the BPI-SF Question #9.

  Baseline and End of DoseTitration, up to 14 days

• Change in Pain Interference from Baseline to Investigational Product Discontinuation

  Pain interference as entered in response to the BPI-SF Question #9.

  Baseline and Investigational Product Discontinuation, up to 23 days

Secondary Outcomes (11)

• Incidence of Treatment Emergent Adverse Events

  Baseline and End of Safety Follow-Up, up to 56 days

• Incidence of Serious Adverse Events

  Baseline and End of Safety Follow-Up, up to 56 days

• Incidence of Adverse Events of Special Interest

  Baseline and End of Safety Follow-Up, up to 56 days

• Incidence of Adverse Events leading to Discontinuation of Study Treatment

  Baseline and End of Safety Follow-Up, up to 56 days

• Change in Electrocardiogram From Baseline to Investigational Product Discontinuation

  Baseline and Investigational Product Discontinuation, up to 23 days

Study Arms (1)

Trichomylin®

EXPERIMENTAL

Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)

Drug: Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)

Interventions

Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene) DRUG

Cancer patients meeting eligibility criteria will receive Trichomylin® and self-titrate to effective dose.

Trichomylin®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has voluntarily agreed to study participation by giving written informed consent and must be ≥18 years of age on the day of signing the informed consent form (ICF).
• Participant has advanced solid malignant tumors not amenable to curative-intent therapy (locally advanced unresectable or metastatic).
• Participant life expectancy is ≥3 months at screening according to investigator's best judgement.
• Participant has a clinical diagnosis of moderate to severe cancer-related pain with average daily pain score to be ≥4 for at least 4 out of the 7-day screening period, despite ongoing opioid treatment, as evidenced by their response to the BPI-SF Question #5 on the Numeric Rating Scale (NRS).
• Participant is taking a stable dose of opioid therapy (Step III according to the World Health Organization \[WHO\] analgesic ladder) for at least 1 week prior to screening to relieve cancer-related pain.
• Participant has adequate organ function, as indicated by the following laboratory values, at screening:
• Baseline serum electrolytes must be within the normal range per local laboratories (for baseline serum electrolytes that are out of range, these may be corrected, and the potential participant may be rescreened).
• Stable renal function (estimated glomerular filtration rate \[eGFR\] \>15).
• Total bilirubin (TBIL) ≤1.5 x upper limit of normal (ULN); or ≤3 x ULN for participants with Gilbert's syndrome.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x ULN or ≤5 x ULN for participants with liver metastases.
• Participant has stable cardiac function, as determined by:
• No clinically significant ECG waveform abnormalities.
• QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤470 msec, as determined by the mean QTcF values from the ECG assessments at screening (one triplicate).
• Participant can tolerate oral medications including capsules.
• Participant is willing to take a medication which may exhibit psychoactive effects.

You may not qualify if:

• Female participants who are pregnant or lactating.
• Participant has uncontrolled psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, or schizophrenia).
• Participant has a family history of schizophrenia.
• Participant has current or history of suicidal behavior or ideation assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
• Participant has any known or suspected history of a diagnosed dependency disorder, including opioid abuse, current heavy alcohol consumption (i.e. more than 10 units of alcohol per week or 4 units on any given day \[1 unit = 150 mL of wine, 260 mL of beer, or 45 mL of 40% alcohol\]), current use of an illicit drug or current non-prescribed use of any prescription drug (Alcohol, Smoking and Substance Involvement Screening Test \[ASSIST\]).
• Participant has engaged in medicinal or recreational use of any cannabinoid containing substance, in any form within the 30 days prior to screening.
• Participant is within the first cycle of a new line of anticancer therapy (including but not limited to chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, or surgery) at the start of the screening period.
• Participant has had any major surgery within 4 weeks prior to screening.
• Participant has an active infection requiring systemic treatment at the start of the study treatment.
• Participant has cirrhosis or severe hepatic impairment defined as AST and ALT \>3 x ULN or \>5 x ULN for participants with liver metastases.
• Participant has any of the following cardiovascular criteria:
• a. Current evidence of unstable angina or another form of symptomatic cardiac ischemia b. Acute myocardial infarction ≤3 months prior to screening c. Heart failure of New York Heart Association Classification III or IV ≤3 months prior to screening d. Grade ≥2 ventricular arrhythmia ≤3 months prior to screening e. Cerebrovascular Accident (CVA) or Grade ≥2 Transient Ischemic Attack (TIA) ≤6 months prior to screening f. Grade ≥2 hypertension that cannot be managed by standard anti-hypertension medications before initiation of treatment g. Syncope or seizure ≤3 months before screening.
• Participant has a history or presence of gastrointestinal disease or other condition known to interfere with the absorption of drugs.
• Participant has intractable vomiting.
• Participant has any other condition or abnormality that, in the investigator's judgement after medical interview, physical examination, and/or screening and baseline investigations, renders participant unfit for the study or precludes the participant's safe participation in and completion of the study.

Sponsors & Collaborators

• ZYUS Life Sciences Inc.: lead

Study Sites (3)

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

The Research Institute of the McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Dronabinol; Cannabidiol; cannabichromene

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Julie Stakiw, MD

  Saskatoon Cancer Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 1, 2024
• Study Start: June 12, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)