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Cannabinoid
Cannabis for Cancer-Related Symptoms (CAFCARS Trial)
Phase 2
Recruiting
Led By Philippa Hawley, FRCPC
Research Sponsored by Pippa Hawley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
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)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16-48 days; 90 minutes after each dose
Summary
This trial will test the effectiveness of three cannabis oil extract combinations (High THC-Low CBD, Low THC-High CBD, or Equal amounts of THC and CBD) in a minimum of 120 cancer patients on 4 cancer-related symptoms: nausea, pain, anxiety and sleep disturbance.
Who is the study for?
This trial is for adults over 19 with stable cancer-related symptoms like nausea, pain, anxiety, or sleep issues. Participants must not use other cannabis products during the study and should have a life expectancy of at least 4 months. They can't join if they're pregnant, on another trial, have certain mental health conditions or substance misuse disorders.
What is being tested?
The trial tests three types of cannabis oil extracts (High THC/Low CBD, Low THC/High CBD, Equal THC/CBD) against a placebo to see which is best for managing cancer-related symptoms. Each participant will try all options in random order to compare effectiveness and safety.
What are the potential side effects?
Possible side effects include dizziness, dry mouth, changes in appetite or mood swings. Serious risks might involve worsening mental health conditions for those predisposed and interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience significant nausea, pain, anxiety, or sleep issues due to my cancer or its treatment.
Select...
I experience significant nausea, pain, anxiety, or sleep problems due to my cancer or its treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 19 years old or older.
Select...
I am mentally capable of understanding and agreeing to participate in the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have mouth conditions that could affect medicine absorption.
Select...
I am on medication that can't mix with cannabinoids and can't be changed.
Select...
I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.
Select...
I have a parent or sibling with schizophrenia.
Select...
I have a history of epilepsy, seizures, or brain cancer spread.
Select...
I cannot or will not avoid using heavy machinery during the study.
Select...
My current symptoms are not caused by my cancer or its treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16-48 days; 90 minutes after each dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16-48 days; 90 minutes after each dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average Patients' Global Impression of Change (PGIC) for overall cancer-related symptoms
Secondary study objectives
Average change from baseline in the Edmonton Symptom Assessment System - revised to include Sleep Disturbance and Night Sweats (ESAS-r-SN) score
Other study objectives
Percent of subjects who prefer each study oil (Oil 1, 2, 3 or 4)
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Low THC/High CBD Cannabis OilExperimental Treatment1 Intervention
THC+THCa = 37mg CBD+CBDA = 784mg Total cannabinoids = 821mg (1.37mg/drop) Dried marijuana equivalent = 6g
Group II: High THC/Low CBD Cannabis OilExperimental Treatment1 Intervention
THC+THCa = 573 mg CBD+CBDA = 0 mg Total cannabinoids = 573 mg (0.95mg/drop) Dried marijuana equivalent = 5g
Group III: Equal amounts of THC/CBD Cannabis OilExperimental Treatment1 Intervention
THC+THCa = 516mg CBD+CBDA = 456mg Total cannabinoids = 972mg (1.62mg/drop) Dried marijuana equivalent = 6g
Group IV: Placebo OilPlacebo Group1 Intervention
Medium Chain Triglyceride (MCT) oil
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabis
2014
Completed Phase 3
~780
Find a Location
Who is running the clinical trial?
Pippa HawleyLead Sponsor
1 Previous Clinical Trials
176 Total Patients Enrolled
Philippa Hawley, FRCPCPrincipal InvestigatorBC Cancer
1 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can be reached by phone.I cannot or will not avoid using heavy machinery during the study.I am 19 years old or older.I am mentally capable of understanding and agreeing to participate in the study.You live in a place where there's a high chance that the study medication could be stolen or used improperly.I experience significant nausea, pain, anxiety, or sleep issues due to my cancer or its treatment.I experience significant nausea, pain, anxiety, or sleep problems due to my cancer or its treatment.You have used cannabis more than once a week in the month before the study.You have had mental health issues related to cannabis or cannabinoids.I have a history of epilepsy, seizures, or brain cancer spread.I am on medication that can't mix with cannabinoids and can't be changed.I can communicate effectively with the research team, with or without a translator.I need to change my current medications due to another health condition while on the study treatment.I am a woman who can still have children and am not using certain birth control methods.My current symptoms are not caused by my cancer or its treatment.My symptoms are expected to remain the same during the study.You currently have a problem with using cannabis or other substances, as determined by a specific test score.You are expected to live for at least 4 months.I have mouth conditions that could affect medicine absorption.I can take care of myself and am up and about more than half of my waking hours.I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.I have a parent or sibling with schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: High THC/Low CBD Cannabis Oil
- Group 2: Low THC/High CBD Cannabis Oil
- Group 3: Equal amounts of THC/CBD Cannabis Oil
- Group 4: Placebo Oil
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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