Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Pain Interference
研究概览
简要总结
Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Aged ≥25 years at Visit 1 (Baseline)
- •Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months
- •Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
- •Desire to use cannabis to treat their symptoms
- •Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months
- •Willing to practice acceptable methods of birth control until completing study medication
排除标准
- •Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
- •Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
- •Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
- •Current use of anti-psychotic medications
- •Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)
- •Liver function tests (Alanine transaminase [ALT] and Aspartate transaminase [AST]) levels ≥2x the upper normal limits
- •Moderate or severe liver disease
- •Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
- •History of seizures
- •For female participant of childbearing potential: Pregnant or lactating at the time of study enrollment or trying to become pregnant. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy
- •Physician response to passive consent indicating contraindications for participation.
- •Unwilling to refrain from cannabis use other than study drug for the entire study duration
- •Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day
研究组 & 干预措施
Full-Spectrum Hemp-Derived CBD (fsCBD)
8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)
干预措施: fsCBD Cannabidiol (Drug)
Broad-Spectrum Hemp-Derived CBD (bsCBD)
8 weeks of use of a daily dose of cannabis (200mg CBD)
干预措施: bsCBD Cannabidiol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Interference
时间窗: Baseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference. Total scores are between 8 and 40, with higher scores meaning more pain interference.
Pain Intensity
时间窗: Baseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (7-day). Scores are between 0-10, with 0 being no pain and 10 being the worst imaginable pain.
Pain Inventory
时间窗: Baseline, 4 weeks, 8 weeks
Brief Pain Inventory (BPI) survey. Measures pain levels, pain interference, and relief from medication, and includes diagrams for labeling pain. For pain levels, various questions ask participants to rate pain on a scale of 0-10, 0 being no pain and 10 being pain as bad as you can imagine. For questions about pain interference, each question is on a scale of 0-10, where 0 does not interfere and 10 completely interferes. BPI is scored as an average of each subsection, where a higher average suggests greater severity of pain/more interference.
Sleep Disturbance
时间窗: Baseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 4a. Scores are separated between the first question (sleep quality) and the remaining 7 questions. For the first question, scores are between 1 and 5, with 1 being very poor sleep quality and 5 being very good sleep quality. The remaining 7 questions are scored individually on a scale of 1--5; for some questions, higher scores mean less disturbance, and for others, a higher score means more disturbance.
Sleep-Related Impairment
时间窗: Baseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment 4a. Scores are between 4 and 20, with higher scores indicating more sleep-related impairment
Depression/Anxiety
时间窗: Baseline, 4 weeks, 8 weeks
Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.
Fatigue
时间窗: Baseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 4a. Scores range from 4-20, with higher scores indicating more fatigue.
Health Related Quality of Life
时间窗: Baseline, 4 weeks, 8 weeks
Health Related Quality of Life Short Form 12 (SF-12). Scores range from 0-100 with higher scores indicating better health.
FACT-Cog Cognitive Function
时间窗: Baseline, 4 weeks, 8 weeks
Functional Assessment of Cognitive Function - Cognitive (FACT-Cog). Scores are transformed such that scores range from 0-132 and higher scores indicate a better quality of life/cognitive function.
Stroop Task Test of Cognitive Function
时间窗: Baseline, 4 weeks, 8 weeks
Stroop Task
DSST Test of Cognitive Function
时间窗: Baseline, 4 weeks, 8 weeks
Digit Symbol Substitution Task (DSST)
Conners Test of Cognitive Function
时间窗: Baseline, 4 weeks, 8 weeks
Conners Continuous Performance Test - Version 3 (CPT-3)
Plasma Cannabinoids
时间窗: Baseline, 4 weeks, 8 weeks
Plasma cannabinoid levels in participants will be measured from biological samples.
PROMIS Pain Intensity (Right Now)
时间窗: 4 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (Right Now). Scores are between 0-10, with 0 being no pain and 10 being the worst imaginable pain.
Drug Effects
时间窗: 4 weeks
Drug Effects Questionnaire (DEQ). Six questions about drug effects with possible answers of "not at all", "somewhat", and "extremely", where higher scores indicate higher drug effects.
ARCI-Marijuana Scale
时间窗: 4 weeks
Addiction Research Center Inventory - Marijuana Scale (ARCI-M). 12 True or false questions where more "true" answers indicate higher drug effects.
Drug Effects - Mood
时间窗: 4 weeks
Profile of Mood States (POMS). Scores are between 28-140, with higher scores indicating higher drug effects.
Drug Effects - Blood Cannabinoids
时间窗: 4 weeks
Acute plasma cannabinoid levels in participants will be measured from blood samples pre-drug administration, on-hour post drug administration, and 2-hours post drug administration at week 4 appointment.
次要结局
- Polypharmacy for Pain(Baseline, 4 weeks, 8 weeks)
- Polypharmacy for Psychiatric Rx(Baseline, 4 weeks, 8 weeks)
- Polypharmacy for Sleep(Baseline, 4 weeks, 8 weeks)
研究者
Angela Bryan
Professor
University of Colorado, Boulder