20 Participants Needed

Trichomylin for Cancer Pain

(UTOPIA-1 Trial)

Recruiting at 3 trial locations
WD
SL
Overseen ByScott Livingstone
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: ZYUS Life Sciences Inc.
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment called Trichomylin® for managing pain in people with advanced cancer. Trichomylin® is a capsule containing a mix of compounds that may help relieve pain. The trial seeks participants with advanced solid tumors who experience moderate to severe pain despite using opioids for at least a week. Those with consistent cancer-related pain and openness to a treatment with potential psychoactive effects may find this trial suitable. As a Phase 2 trial, this research measures how well Trichomylin® works in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

You can continue taking your current opioid medication, but you must stop using certain herbal supplements and products like grapefruit juice and St. John's wort 7 days before the trial starts. You also need to avoid any cannabis products for 30 days before the trial and during the study.

Is there any evidence suggesting that Trichomylin® is likely to be safe for humans?

Research has shown that Trichomylin®, which contains cannabinoids (natural compounds from cannabis), has been studied for its safety in managing cancer pain. One study found that a THC:CBD extract, similar to Trichomylin®, relieved pain in patients with advanced cancer whose pain wasn't fully controlled by strong painkillers. This suggests these compounds can be safe for such patients.

Another review of medical cannabis for cancer pain found it can reduce chronic pain in advanced cancer patients. While these studies support the safety of treatments like Trichomylin®, some patients may experience side effects, such as dizziness or dry mouth, which are common with cannabinoid use.

This trial is a Phase 2 study, aiming to further test the safety and effectiveness of Trichomylin®. Earlier research has shown promise, but more data is needed to confirm its safety for wider use.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer pain, which often rely on opioids and other pharmaceuticals, Trichomylin® is unique because it harnesses the power of cannabinoids, specifically delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), and cannabichromene (CBC). This combination of cannabinoids targets pain through multiple pathways, potentially offering a more comprehensive pain management solution with fewer side effects. Researchers are excited about Trichomylin® because it represents a shift towards using natural compounds to manage cancer pain, which could improve patients' quality of life by reducing reliance on traditional painkillers.

What evidence suggests that Trichomylin® might be an effective treatment for cancer pain?

Research has shown that cannabinoids, like those in Trichomylin, have produced mixed results in relieving cancer pain. One study found that cannabinoids did not reduce cancer pain. However, some components of Trichomylin, such as cannabichromene, demonstrated strong effects against cancer cells in lab tests. Another study found some pain relief with a different cannabinoid formula. While cannabinoids show promise, the effectiveness of Trichomylin for cancer pain remains under investigation in this trial.16789

Who Is on the Research Team?

JS

Julie Stakiw, MD

Principal Investigator

Saskatoon Cancer Centre

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancer who have moderate to severe pain despite taking stable long-acting opioids. They should expect to live at least 3 more months, have normal blood electrolytes, stable kidney function, and acceptable liver enzyme levels. People with significant heart abnormalities or those whose cancer can still be cured by surgery are not eligible.

Inclusion Criteria

My doctor believes I have at least 3 months to live.
My kidney function is stable with an eGFR over 15.
My blood mineral levels are normal or have been corrected to normal.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Dose Titration

Participants undergo a titration phase to determine the optimal dose of Trichomylin® for symptom relief with tolerable side effects

up to 14 days

Stable Dose Assessment

Participants are assessed for 5 days at the stable dose determined during titration

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 56 days

What Are the Treatments Tested in This Trial?

Interventions

  • Trichomylin®
Trial Overview The study tests Trichomylin®, a capsule combining three cannabis-derived compounds, aiming to relieve chronic pain in patients with advanced cancer already on opioid therapy. It's a small-scale preliminary study involving up to 20 participants.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Trichomylin®Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ZYUS Life Sciences Inc.

Lead Sponsor

Trials
2
Recruited
60+

Citations

Tetrahydrocannabinol and Cannabidiol for Pain Treatment ...The results suggested that cannabinoids are not effective in reducing cancer pain, with the cannabinoid treatment group experiencing ...
Trial | NCT06533657This 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 ...
NCT06266611 | Cannabis for Palliative Care in CancerPROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference. Total scores are between 8 and 40, with higher scores meaning more pain ...
Potent anti-cancer effects of cannabichromene and delta-9- ...Results. Three commercial C. sativa strains, PARIS, DQ, and sCBD, were found to have the most potent anticancer effects on bladder cancer cells.
The Efficacy and Safety of Use of Cannabis and Cannabinoid ...(1.29% THC )7.13% reduction in pain compared to the placebo, and the (3.53% THC) treatment shows an approximate 0.35% reduction in pain compared ...
Cannabinoids for Medical Use: A Systematic Review and ...This meta-analysis summarizes the effectiveness of cannabis and cannabinoids for managing medical and psychotic disorders, including chemotherapy-induced.
Study Details | NCT04808531 | NanaBis™ an Oro-buccal ...This trial uses an alternative method to demonstrate the analgesic efficacy of NanaBis™ as a monotherapy in cancer participants.
Multicenter, Double-Blind, Randomized, Placebo ...This study shows that THC:CBD extract is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids.
A selective review of medical cannabis in cancer pain ...There is evidence suggesting that medical cannabis reduces chronic or neuropathic pain in advanced cancer patients.
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