Cannabis For Cancer-Related Symptoms

Launched by PIPPA HAWLEY · May 10, 2019

Keywords

ClinConnect Summary

This clinical trial, called "Cannabis For Cancer-Related Symptoms," is investigating how different cannabis oil combinations can help relieve symptoms related to cancer, such as pain, nausea, anxiety, and trouble sleeping. The study will compare three types of cannabis oil—one high in THC (the part that can make you feel high), one low in THC but high in CBD (which is known for its calming effects), and one that has equal amounts of both. Participants will receive either one of these oils or a placebo (a non-active oil) to see which is most effective for managing their symptoms.

To be eligible for this study, you need to be at least 19 years old and experiencing distressing symptoms related to cancer or its treatment. You should be able to commit to not using other cannabis products during the study and have a good level of health to participate. If chosen, you can expect to try one of the cannabis oils and report on how it affects your symptoms over time. The trial is currently recruiting participants and aims to gather valuable information to help future patients manage their cancer-related symptoms more effectively.

Gender

ALL

Eligibility criteria

• 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).