Cannabis For Cancer-Related Symptoms

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 cancertreatment-related symptoms which is causing distress: Nausea; Pain; Anxiety; SleepDisturbance; (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 productsfor the duration of the study;

• Able to reliably communicate with the research team, either directly or through atranslator;

• 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 asdefined 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 thanonce a week during the month prior to study entry;

• They have a history of psychosis with, or other intolerance to cannabis orcannabinoids;

• They have an active psychiatric disorder likely, in the investigator's opinion, tointerfere with adherence to study protocol;

• They have any concurrent condition likely to interfere with completion of the studyprotocol, 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) notusing effective, non-hormonal means of contraception (intrauterine contraceptivedevice, 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. oralmucositis;

• They are taking medications that might be affected by an interaction withcannabinoids in a clinically significant manner (CYP1A1, 1A2, and 1B1) and cannot beswitched 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 withinthe 48 days on study treatment.

• They have serious cardiovascular disease such as ischemic heart disease, includingarrhythmias, poorly controlled hypertension, severe heart failure, recent (within 6months) 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 theduration of their participation in this study.

• They are unable or unwilling to refrain from consuming alcohol for the duration oftheir participation in this study.

• They expect to leave Canada during the study period, as the study products cannot betaken across any international border (land, sea or air).