Cancer PainPhase 2UTOPIA-1NCT06533657
Unique Treatment of Oncology Pain in Advanced Cancer
A Phase 2 study testing Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene) in people with Cancer Pain, run by ZYUS Life Sciences Inc. at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesCanada
- Study dates
- 12 Jun 2025to 15 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 24Show fewer
- 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.
- Participant must discontinue the use of the following medications 7 days before the start of study intervention and for the duration of the trial, unless in the opinion of the investigator and sponsor, the medication will not interfere with the study: herbal supplements or related products which are cytochrome P450 (CYP) 2E1, CYP3A4, or P-glycoprotein substrates, or which are strong inhibitors of the CYP3A4 and/or CYP3A5 pathways or which are known CYP3A4 inducers (this includes grapefruit and Seville oranges juice or related products, and St. John's wort).
- Participant must not engage in medicinal or recreational use of any cannabinoid containing substance, in any form, within 30 days prior to screening and be willing to abstain from medicinal or recreational use of cannabis and other cannabinoid compounds (other than the Investigational Product) for the duration of the study.
- Participant must have a negative urine drug screen for cannabinoids at screening and prior to dosing at Day 1; one repeat test may be conducted for a suspected false positive result.
- Participant must not have any current or past allergic or adverse reaction or known sensitivity to olive oil, gelatine, glycerin, and titanium dioxide, or to cannabinoid-like substances (including but not limited to dronabinol, marinol, nabilone, marijuana, cannabis, THC, or cannabinoid oil).
- Female participants are eligible to enter and participate in the study if they are of:
- Non-childbearing potential.
- Childbearing potential with a negative serum pregnancy test at screening (within 7 days of the first dose of Investigational Product) and agree to use contraception before study entry and throughout the study until 3 months after the last administered dose of the Investigational Product.
- Male participants are eligible to enter and participate in the study if they are vasectomized or agree to the use of contraception during the study treatment period and for at least 3 months after the last administered dose of the Investigational Product.
- Participants, in the opinion of the investigator, should understand the nature of the study, be able to participate in all planned assessments, complete all required tests, and be likely to comply with all study procedures.
Who cannot join
- 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.
Show all 16Show fewer
- 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:
- 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.
- Participant has concurrent participation in another therapeutic clinical trial or participation in another clinical trial within 30 days prior to the enrolment in this trial.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H3H 2R9
CancerCare Manitoba
Winnipeg, Manitoba
About this study
Official title: 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
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.
Read the 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
- Being tested
- Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)
- Keywords
- Cannabinoid, Safety and Tolerability, Preliminary Efficacy, Opioid-sparing
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Trichomylin® | Experimental | Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene) Receives: Drug: Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Investigational Product Discontinuation, up to 23 days
Secondary outcomes (11)
Incidence of Treatment Emergent Adverse Events
The severity of an adverse events (AE) is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (NCI 2017). The incidence of AEs will be presented as the number (percentage) of participants with treatment emergent adverse events (TEAEs) by system organ class and Preferred Term using the most current Medical Dictionary for Regulatory Activities (MedDRA) available at the time of study commencement.
Measured: Baseline and End of Safety Follow-Up, up to 56 days
Incidence of Serious Adverse Events
The incidence of serious adverse events (SAE) will be presented as the number (percentage) of participants with SAEs by system organ class and Preferred Term using the most current Medical Dictionary for Regulatory Activities (MedDRA) available at the time of study commencement.
Measured: Baseline and End of Safety Follow-Up, up to 56 days
Incidence of Adverse Events of Special Interest
The incidence of adverse events of special interest (AESI) will be presented as the number (percentage) of participants with AESIs by system organ class and Preferred Term using the most current Medical Dictionary for Regulatory Activities (MedDRA) available at the time of study commencement.
Measured: Baseline and End of Safety Follow-Up, up to 56 days
Incidence of Adverse Events leading to Discontinuation of Study Treatment
The incidence of adverse events (AE) leading to discontinuation of study treatment will be presented as the number (percentage) of participants with AEs by system organ class and Preferred Term using the most current Medical Dictionary for Regulatory Activities (MedDRA) available at the time of study commencement.
Measured: Baseline and End of Safety Follow-Up, up to 56 days
Change in Electrocardiogram From Baseline to Investigational Product Discontinuation
A triplicate 12-lead electrocardiogram (ECG) will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and [QTc] intervals.
Measured: Baseline and Investigational Product Discontinuation, up to 23 days
Change in Brief Pain Inventory Short Form from Baseline to Investigational Product Discontinuation
The 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.
Measured: Baseline and Investigational Product Discontinuation, up to 23 days
Proportion of responders in Brief Pain Inventory Short Form from Baseline to Investigational Product Discontinuation
The 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. Response is defined as having a decrease in pain from baseline by ≥30% at the Investigational Product discontinuation visit.
Measured: Baseline and Investigational Product Discontinuation, up to 23 days
Change in Depression, Anxiety and Stress Scale - 21 Items from Baseline to Investigational Product Discontinuation
The Depression, Anxiety and Stress Scale- 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. By examining these subscales separately, DASS-21 provides a comprehensive picture of an individual's emotional state, aiding therapists, and researchers in identifying the primary areas of concern.
Measured: Baseline and Investigational Product Discontinuation, up to 23 days
Change in Quality of Life and Functional Status from Baseline to Investigational Product Discontinuation
The European Organization for Research and Treatment of Cancer core Quality of Life (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological, and social functions. The questionnaire is composed of multi-item scales and single items (Version 3.0).
Measured: Baseline and Investigational Product Discontinuation, up to 23 days
Change in Subjective Measures of Symptom Change from Baseline to Investigational Product Discontinuation
The Patient Global Impression of Change (PGIC) is a subjective measure of symptom change. Participants rate their change on a 7-point scale that ranges from "very much improved" to "very much worse", with "no-change" as the mid-point.
Measured: Baseline and Investigational Product Discontinuation, up to 23 days
Use of Oral Morphine Equivalents from Baseline to Investigational Product Discontinuation
Rescue analgesia requirements, specifically use of opioid medications, both prescription and over the counter (OTC), will be documented at baseline and for the duration of the study. Opioid medications will be converted to morphine equivalent doses (MEDD) for comparison and evaluation purposes.
Measured: Baseline and Investigational Product Discontinuation, up to 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start12 Jun 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZYUS Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Stakiw, MD, Study director, Saskatoon Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533657
- Sponsor's protocol ID
- Z-TRI-10002A
- Acronym
- UTOPIA-1
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06533657
- Acronym / sponsor ID
- UTOPIA-1 / Z-TRI-10002A
- Conditions
- Cancer Pain
- Keywords
- Cannabinoid, Safety and Tolerability, Preliminary Efficacy, Opioid-sparing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- ZYUS Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trichomylin® | Experimental | Drug: Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (16 listed)
- 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]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Trichomylin® |
Primary outcome
Number of Participants That Reach the Stable Dose during Dose Titration
Time frame: Baseline (i.e. Day 1 Dose Titration) and Stable Dose Day 1, up to 14 days
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".
Change in Average Pain Scores from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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.
Proportion of Responders to Average Pain from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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.
Number of Participants That Reach the Stable Dose during Dose Titration and Respond to Average Pain from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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.
Change in Average Pain from Baseline to End of the Titration
Time frame: Baseline and End of Dose Titration, up to 14 days
Average pain as entered in response to the BPI-SF Question #5.
Change in Pain Interference from Baseline to End of the Titration
Time frame: Baseline and End of DoseTitration, up to 14 days
Pain interference is scored as the mean of the seven interference items and entered in response to the BPI-SF Question #9.
Change in Pain Interference from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
Pain interference as entered in response to the BPI-SF Question #9.
11 secondary outcomes
Incidence of Treatment Emergent Adverse Events
Time frame: Baseline and End of Safety Follow-Up, up to 56 days
Incidence of Serious Adverse Events
Time frame: Baseline and End of Safety Follow-Up, up to 56 days
Incidence of Adverse Events of Special Interest
Time frame: Baseline and End of Safety Follow-Up, up to 56 days
Incidence of Adverse Events leading to Discontinuation of Study Treatment
Time frame: Baseline and End of Safety Follow-Up, up to 56 days
Change in Electrocardiogram From Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
Change in Brief Pain Inventory Short Form from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
Proportion of responders in Brief Pain Inventory Short Form from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
Change in Depression, Anxiety and Stress Scale - 21 Items from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
Change in Quality of Life and Functional Status from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
Change in Subjective Measures of Symptom Change from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
Use of Oral Morphine Equivalents from Baseline to Investigational Product Discontinuation
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Stakiw, MD study director
Saskatoon Cancer Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene) in people with Cancer Pain, run by ZYUS Life Sciences Inc. at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Reach the Stable Dose during Dose Titration (time frame: Baseline (i.e. Day 1 Dose Titration) and Stable Dose Day 1, up to 14 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.