Unique Treatment of Oncology Pain in Advanced Cancer (NCT06533657) | Clinical Trial Compass
CompletedPhase 2
Unique Treatment of Oncology Pain in Advanced Cancer
Canada11 participantsStarted 2025-06-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants That Reach the Stable Dose during Dose Titration
Timeframe: Baseline (i.e. Day 1 Dose Titration) and Stable Dose Day 1, up to 14 days
2
Change in Average Pain Scores from Baseline to Investigational Product Discontinuation
Timeframe: Baseline and Investigational Product Discontinuation, up to 23 days
3
Proportion of Responders to Average Pain from Baseline to Investigational Product Discontinuation
Timeframe: Baseline and Investigational Product Discontinuation, up to 23 days
4
Number of Participants That Reach the Stable Dose during Dose Titration and Respond to Average Pain from Baseline to Investigational Product Discontinuation
Timeframe: Baseline and Investigational Product Discontinuation, up to 23 days
5
Change in Average Pain from Baseline to End of the Titration
Timeframe: Baseline and End of Dose Titration, up to 14 days
6
Change in Pain Interference from Baseline to End of the Titration
Timeframe: Baseline and End of DoseTitration, up to 14 days
. 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).
Exclusion criteria
. 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.
7
Change in Pain Interference from Baseline to Investigational Product Discontinuation
Timeframe: Baseline and Investigational Product Discontinuation, up to 23 days