Cannabis For Cancer-Related Symptoms
关键词
抽象
描述
Investigators propose a study consisting of a series of N-of-1 trials comparing 3 different active cancer-related symptom management treatments against a placebo treatment in terms of effectiveness and safety. Using formal statistical modeling, effectiveness will be assessed for single patients, for the entire patient population and for relevant subsets of the patient population defined by baseline patient characteristics. Safety will be assessed in a descriptive fashion for all patients who are part of the safety population.
Subjects will be on treatment in the study for a minimum of 16 days with the opportunity to repeat the 16-day cycle of cancer-related symptom treatment with all four oil extracts up to 2 more times. The extracts will be supplied to subjects at the beginning of the study in four distinct 30-ml bottles, randomly labelled as #1, #2, # 3 and # 4. The random labelling will be generated via a computer-generated randomization code.
The study will include at least 120 adult subjects (recruitment target 150 to allow for drop-outs) residing in Canada who have symptoms from cancer and/or from cancer treatment but will exclude patients with active recreational use, cannabis use disorder, or high risk of diversion.
Each treatment cycle will have a length of 16 days and will consist of 4 four-day periods. The first 2 days of each 4-day period will be a washout period where data will not be used for the analysis of effectiveness, to make sure there is no confusion with effects from the prior period. Subjects can use one and only one cannabis oil extract during each period to treat their cancer-related symptom(s).
Given a cannabis oil extract, the daily use of that extract by patients will involve the following: On each day within a specific treatment cycle, the patient will be asked to take a minimum of 3 drops of that extract per day (e.g., in the morning) and if any of the four major symptoms (nausea, pain, anxiety, and sleep disturbance) continue to trouble the patient as the day progresses, they will be instructed to take up to 3 drops every 4 hours for a maximum of 6 times a day (for a total of no more than 18 drops per day).
All subjects will be instructed to use the following validated scales: Edmonton Symptom Assessment Scale (ESAS) and Patients' Global Impression of Change Scale (PGIC). The revised ESAS will be used modified to include sleep disturbance (previously validated), and added night sweats in replacement of the additional symptom option (ESAS-r-SN) because of reports of benefit of medical cannabis for this symptom and its relevance for sleep disturbance.This is in order to capture a complete picture of potential factors contributing to sleep disturbance. Additionally, subjects will be instructed to fill in a study medication use log which will record the timing and dose of each extract applications, any side effects associated with each application, as well as any rescue medication (if taken).
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 05/08/2019 |
| 提交的预估入学人数: | 05/09/2019 |
| 首次发布: | 05/12/2019 |
| 上次提交的更新: | 07/09/2020 |
| 最近更新发布: | 07/13/2020 |
| 实际学习开始日期: | 07/31/2020 |
| 预计主要完成日期: | 06/30/2021 |
| 预计完成日期: | 06/30/2021 |
状况或疾病
干预/治疗
Drug: Cannabis
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: High THC/Low CBD Cannabis Oil THC+THCa ≥ 500 mg CBD+CBDA≤ 5 mg Total cannabinoids = 505 mg (0.83mg/drop) Dried marijuana equivalent = 2.5g | |
| Experimental: Low THC/High CBD Cannabis Oil THC+THCa ≤25 mg CBD+CBDA≥ 500 mg (0.83mg/drop) Total cannabinoids = 525 mg Dried marijuana equivalent = 2.5g | |
| Experimental: Equal amounts of THC/CBD Cannabis Oil THC+THCa ~ 250 mg (0.415mg/drop) CBD+CBDA~ 250 mg (0.415mg/drop) Total cannabinoids ~ 500 mg (0.83mg/drop) Dried marijuana equivalent = 2.5g | |
| Placebo Comparator: Placebo Oil A 2:1 mixture of Rosemary oil + Unrefined Coconut oil |
资格标准
| 有资格学习的年龄 | 19 Years 至 19 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 driving a vehicle or 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). |
结果
主要结果指标
1. Average Patients' Global Impression of Change (PGIC) for overall cancer-related symptoms [16-48 days; 90 minutes after each dose]
次要成果指标
1. Average change from baseline in the Edmonton Symptom Assessment System - revised to include Sleep Disturbance and Night Sweats (ESAS-r-SN) score [16-48 days; once daily]
其他成果措施
1. Percent of subjects who prefer each study oil (Oil 1, 2, 3 or 4) [16-48 days]
