Unique Treatment of Oncology Pain in Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-12

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cannabis Oil for Pain Effectiveness

NCT03522467

Cancer Chronic Pain

UNKNOWN PHASE2

Treatment for Chronic Pain in Patients With Advanced Cancer

NCT00003687

Chronic Myeloproliferative Disorders Leukemia Lymphoma +6 more

COMPLETED PHASE3

Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain

NCT03564548

Cancer Breakthrough Cancer Pain

UNKNOWN PHASE2

Improving Pain Disability With the Use of Oral Cannabinoids

NCT05351905

Chronic Pain Opioid Use Cannabis

COMPLETED NA

Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients

NCT01207206

Cancer Pain Tolerance

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trichomylin®

Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)

Group Type EXPERIMENTAL

Trichomylin® capsule (5 mg delta-9-tetrahydrocannabinol: 5 mg cannabidiol: 5 mg cannabichromene)

Intervention Type DRUG

Cancer patients meeting eligibility criteria will receive Trichomylin® and self-titrate to effective dose.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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).
2. Participant has advanced solid malignant tumors not amenable to curative-intent therapy (locally advanced unresectable or metastatic).
3. Participant life expectancy is ≥3 months at screening according to investigator's best judgement.
4. 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).
5. 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.
6. Participant has adequate organ function, as indicated by the following laboratory values, at screening:

1. 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).
2. Stable renal function (estimated glomerular filtration rate \[eGFR\] \>15).
3. Total bilirubin (TBIL) ≤1.5 x upper limit of normal (ULN); or ≤3 x ULN for participants with Gilbert's syndrome.
4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x ULN or ≤5 x ULN for participants with liver metastases.
7. Participant has stable cardiac function, as determined by:

1. No clinically significant ECG waveform abnormalities.
2. 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).
8. Participant can tolerate oral medications including capsules.
9. Participant is willing to take a medication which may exhibit psychoactive effects.
10. 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).
11. 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.
12. 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.
13. 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).
14. Female participants are eligible to enter and participate in the study if they are of:

1. Non-childbearing potential.
2. 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.
15. 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.
16. 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.

Exclusion Criteria

1. Female participants who are pregnant or lactating.
2. Participant has uncontrolled psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, or schizophrenia).
3. Participant has a family history of schizophrenia.
4. Participant has current or history of suicidal behavior or ideation assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
5. 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 \[ASSIST\]).
6. Participant has engaged in medicinal or recreational use of any cannabinoid containing substance, in any form within the 30 days prior to screening.
7. 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.
8. Participant has had any major surgery within 4 weeks prior to screening.
9. Participant has an active infection requiring systemic treatment at the start of the study treatment.
10. Participant has cirrhosis or severe hepatic impairment defined as AST and ALT \>3 x ULN or \>5 x ULN for participants with liver metastases.
11. Participant has any of the following cardiovascular criteria:

a. 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.
12. Participant has a history or presence of gastrointestinal disease or other condition known to interfere with the absorption of drugs.
13. Participant has intractable vomiting.
14. 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.
15. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No