Clinical trial · Interventional
Cannabis For Cancer-Related Symptoms
A Randomized, Double-Blind, Placebo-Controlled, Multiple Crossover N-of-1 Study Design of the Use of Medicinal Cannabis Oil-Based Extracts for Symptom Management in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical evidence is urgently needed to be able to advise patients on which cannabis-based products to take, or to avoid, in managing cancer-related symptoms. This trial was therefore designed to determine which cannabis extract combination (High THC-Low CBD, Low THC-High CBD, or Equal amounts of THC and CBD) is most effective at treating cancer related symptoms for each patient relative to placebo. Investigators propose a randomized, double-blind, N-of-1 trial to test the effectiveness of each cannabis extract combination using cannabis oils in a minimum of 120 patients on 4 cancer-related symptoms: nausea, pain, anxiety and sleep disturbance. The three active treatments will be the following cannabis oil extract combinations: High THC/Low CBD, Low THC/High CBD, and Equal amounts of THC/CBD. * THC = Tetrahydrocannabinol * CBD = Cannabidiol The placebo treatment will be Medium Chain Triglyceride (MCT) oil. The active oils and the placebo are similar in taste, smell and effectively blind subjects. Primary objective: To identify whether there is an active cannabis extract that is more effective than placebo in managing overall cancer-related symptoms for individual subjects who completed at least 1 treatment cycle for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Secondary objective: To identify whether there is a cannabis extract that is more effective than placebo in managing each of the 4 index symptoms (pain, nausea, anxiety and sleep disturbance) for individual subjects who completed at least 1 treatment cycle, for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Tertiary objectives: To investigate the safety (e.g., serious adverse events) of each of the three cannabis extracts. To identify subject preference of each of the 4 oils (if any).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Nausea | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cannabis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- High THC/Low CBD Cannabis Oil
- description
- THC+THCa = 573 mg CBD+CBDA = 0 mg Total cannabinoids = 573 mg (0.95mg/drop) Dried marijuana equivalent = 5g
- interventionNames
- Drug: Cannabis
- type
- EXPERIMENTAL
- label
- Low THC/High CBD Cannabis Oil
- description
- THC+THCa = 37mg CBD+CBDA = 784mg Total cannabinoids = 821mg (1.37mg/drop) Dried marijuana equivalent = 6g
- interventionNames
- Drug: Cannabis
- type
- EXPERIMENTAL
- label
- Equal amounts of THC/CBD Cannabis Oil
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * At least 19 years of age; * Competent to consent to participation in the study; * Must have at least one of the following cancer-related symptoms or a cancer treatment-related symptoms which is causing distress: Nausea; Pain; Anxiety; Sleep Disturbance; (based on ESAS-r-SN score ≥4/10) * Symptom(s) are expected to be stable throughout the duration of the study; * Expecting to live for at least 4 months; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; * Willing to commit to not taking cannabis in any form other than the study products for the duration of the study; * Able to reliably communicate with the research team, either directly or through a translator; * Accessible by telephone. Exclusion Criteria: * Their current symptoms are not related to cancer or cancer treatment; * They have a current cannabis or other substance dependence or misuse disorder as defined by the revised Cannabis Use Disorder Identification Test (CUDIT-R) score of 8 or above; * They admit to cannabis use for any purpose (recreational or medicinal) more than once a week during the month prior to study entry; * They have a history of psychosis with, or other intolerance to cannabis or cannabinoids; * They have an active psychiatric disorder likely, in the investigator's opinion, to interfere with adherence to study protocol; * They have any concurrent condition likely to interfere with completion of the study protocol, such as allergy to any component of the study products; * They are pregnant or planning to get pregnant or they are lactating females; * They are women of childbearing potential (\<2 years after last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal); * They have reproductive potential and fail to use adequate birth control; * They are on another clinical trial or expect to start one prior to study completion; * They have oral disease which might impair trans-mucosal absorption, e.g. oral mucositis; * They are taking medications that might be affected by an interaction with cannabinoids in a clinically significant manner (CYP1A1, 1A2, and 1B1) and cannot be switched to a different medication; * They live in an environment with high risk of theft or diversion of study products; * They have a concurrent condition that requires changes to current medications within the 48 days on study treatment. * They have serious cardiovascular disease such as ischemic heart disease, including arrhythmias, poorly controlled hypertension, severe heart failure, recent (within 6 months) MI. * They have first degree relatives with schizophrenia. * They have history of epilepsy or repeated seizures or brain metastases. * They are unable or unwilling to refrain from operating heavy machinery for the duration of their participation in this study. * They are unable or unwilling to refrain from consuming alcohol for the duration of their participation in this study. * They expect to leave Canada during the study period, as the study products cannot be taken across any international border (land, sea or air).
References
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