Unique Treatment of Oncology Pain in Advanced Cancer
NCT Number: NCT06533657
Acronym: UTOPIA-1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cancer Pain
Interventions: DRUG: Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)
Sponsor: ZYUS Life Sciences Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2025-03

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., 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)., 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., 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., Baseline and Investigational Product Discontinuation, up to 23 days