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.
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-09-01
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Cancer patients meeting eligibility criteria will receive Trichomylin® and self-titrate to effective dose.
Eligibility
primary outcomes
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".
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.
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.
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.
Time frame: Baseline and End of Dose Titration, up to 14 days
secondary outcomes
Time frame: Baseline and End of Safety Follow-Up, up to 56 days
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.
Time frame: Baseline and End of Safety Follow-Up, up to 56 days
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.
Time frame: Baseline and End of Safety Follow-Up, up to 56 days
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.
Time frame: Baseline and End of Safety Follow-Up, up to 56 days
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.
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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.
Publications
No exact PMID-linked public article is currently readable locally.
Average pain as entered in response to the BPI-SF Question #5.
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.
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
Pain interference as entered in response to the BPI-SF Question #9.
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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.
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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.
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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.
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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).
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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.
Time frame: Baseline and Investigational Product Discontinuation, up to 23 days
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.