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Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients

2019年10月4日 更新者：Tetra Bio-Pharma

Safety and Efficacy of PPP001-kit for Improving Health Related Quality of Life in Advanced Cancer Patients With Uncontrolled Pain: A Randomized, Double-blind, Placebo-Controlled, Parallel Group Study

Cancer causes pain in many of the patients that it affects. Physicians specialized in palliative care help advanced cancer patients to maintain as good pain control as possible through the use of medications such as opioids. Even with palliative care and optimal use of medications, many patients still suffer enormously as the cancer spreads. Because of this, some cancer patients also try or use cannabis in different ways to relieve their pain and improve the way they feel. However, there has not been much high-quality research done yet to prove whether or not cannabis products are truly useful to relieve severe cancer pain. This study is to test if advanced cancer patients who use inhaled medical cannabis (PPP001), in addition to palliative care management, will experience improvement in quality of life and relieve uncontrolled pain, providing safety conditions.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
终止

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 to improve quality of life (HRQoL) and reduce pain intensity, in patients with uncontrolled cancer pain and incurable malignancy.

Nine hundred forty six adult patients, male and female, with chronic cancer pain (at least 3 months in duration) and advanced disease, with an average weekly pain intensity score greater than 4 on a 11 points Numerical Rate Scale (NRS), will be prospectively recruited and invited to participate in this trial.

Informed consent will be obtained by a Research Assistant.

After baseline documentation with standardized scales, patients will be randomized to one of 2 parallel groups:

Group A: 4 weeks PPP001-kit three times daily; Group B: 4 weeks placebo-kit three times daily; The inhalation of PPP001 or placebo-kit will be allowed three times a day at 4-6 hour intervals. Rescue medication will also be allowed.

Patients will have a dose titration phase during the first week, followed by an additional 3-week period of treatment. The dose escalation will allow patients to adapt to the potential AEs of cannabis.

Patients will have follow-up after 1 week and 4 weeks of treatment. Once the patient has completed 4 weeks of inhaled PPP001 or placebo, it will be rolled into a long-term follow-up phase until drop-out or death. All patients, including the ones in the placebo group, will be allowed to receive the active treatment once the 4-weeks trial has finished, and continue it until death or drop-out.

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (实际的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
8

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Quebec
      • Montréal、Quebec、加拿大、H2L 3K9
        • Santé Cannabis

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Written informed consent
  2. Adult male and female patients at least 18 years of age
  3. Subject agreed to follow the protocol
  4. Advanced cancer for which there is no known curative therapy
  5. Patients experiencing pain ≥4 on NRS due to cancer related pain
  6. Life expectancy six weeks or longer
  7. PPI score less than or equal to 4 (survival more than 6 weeks)
  8. PPS greater than or equal 70%
  9. PaP Score Group A (30-day survival probability >70%)
  10. An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  11. The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment
  12. The patient is using no more than one type of breakthrough opioid analgesia
  13. Normal cognitive status according to MDAS and MiniCog
  14. Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L)
  15. Normal renal function (defined as serum creatinine level <133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60)
  16. The patient is able to perform deep inhalations and hold breath for at least 5 to 10 seconds. If there is any pulmonary disease diagnosed previously (obstructive and/or restrictive pathology), the patient must be able to perform a maximal inhalation of at least 12-15 ml/kg measured with an incentive spirometer, followed by a normal exhalation
  17. Ability to read and respond to questions in French or English.
  18. Previous or current use of opioid analgesics (at least 1 week)

  19. A female volunteer must meet one of the following criteria:

    If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose. An acceptable method of contraception includes one of the following:

    • Abstinence from heterosexual intercourse
    • Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
    • Intrauterine device (with or without hormones)
    • Condom with spermicide or condom with intravaginally applied spermicide If of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least one year without menses)

  20. A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must meet the following criteria:

    • Participant is unable to procreate, defined as surgically sterile (i.e. has undergone a vasectomy within the last 6 months)
    • Participant agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration. An acceptable method of contraception includes one of the following:

A. Abstinence from heterosexual intercourse. B. Condom with spermicide or condom with intravaginally applied spermicide

Exclusion Criteria:

  1. Pain due to other causes different than cancer related pain
  2. Previous serious adverse event or hypersensitivity to cannabis or cannabinoids
  3. Inability to understand and comply with the instructions of the study
  4. Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
  5. Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5)
  6. Life-time history of dependence on cannabis or diagnosis of cannabis use disorder (CUD) according to the DSM 5
  7. Life-time history of DSM 5 schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids
  8. Current or history of suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS) approved by FDA in 2012 for assessment of suicidal ideation and behaviour
  9. Pregnant, breast-feeding or female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective)
  10. Hepatic impairment (aspartate aminotransferase more than three times normal) or renal function impairment (serum creatinine level >133 µmol/L, Estimated Glomerular Filtration Rate (eGFR) <60)
  11. Cognitive impairment according to MDAS and MiniCog
  12. Patient has any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
  13. Cancer treatments that may interfere with stability of treatment (epidural, radiotherapy, chemotherapy, hormonal therapy)
  14. Epilepsy
  15. The patient is currently using or has used cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
  16. Positive urine drug screen for cannabinoids and other potential abuse substances (e.g. alcohol, cocaine, amphetamines and methamphetamines, hallucinogens, unprescribed opioids and ketamine, etc.)
  17. Participation in another clinical trial within 30 days of enrolment in our trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
安慰剂比较：不含四氢大麻酚的安慰剂
280 毫克干燥提取的大麻颗粒（每颗粒 0% THC / 0.6% CBD）
组合产品：placebo
1 pellet smoked three times a day with titanium pipe (280 mg dried cannabis pellet - 0% THC / 0.6% CBD per pellet)
其他名称：
  • 钛管
实验性的：smoked cannabis (PPP001)
280 mg dried cannabis pellet -(9% THC / 2% CBD per pellet)
组合产品：PPP001
1 pellet smoked three times a day with titanium pipe (280 mg dried cannabis pellet - 9% THC / 2% CBD per pellet)
其他名称：
  • 钛管

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
improve Health Related Quality of Life (HRQoL) of patients with uncontrolled cancer pain and incurable malignancy
大体时间：Change from Baseline in HRQoL at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months.
Does the daily use of PPP001-kit improve European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). Scale range is 1 to 4; 1 (Not at All) being the worst rating to the maximal rating of 4 (Very Much).
Change from Baseline in HRQoL at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months.

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Does the daily use of PPP001-kit improve uncontrolled cancer pain
大体时间：Change from Baseline in BPI-SF at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Changes in pain as measured by the Brief Pain Inventory-Short Form (BPI-SF) scale. Scale range is 0 to 10; 0 (No pain) being the best rating to the maximal rating of 10 (Pain as bad as you can imagine).
Change from Baseline in BPI-SF at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Does the daily use of PPP001-kit improve symptom burden
大体时间：Change from Baseline in ESAS-r-CS at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Changes in symptom burden as measured by the revised Edmonton Symptom Assessment System version with Constipation and Sleep was added to assess improvement in symptom burden (ESAS-r-CS). Scale range is 0 to 10; 0 (No symptom) being the best rating to the maximal rating of 10 (Worst possible score for symptom).
Change from Baseline in ESAS-r-CS at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Does the daily use of PPP001-kit improve functional status
大体时间：Change from Baseline in PPSv2 at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Changes in Palliative Performance Scale (PPSv2) version 2. Scale range is a left to right and downward scale for participant to find the best description of their palliative performance. Worst being 0% score representing Dead to PPS 100% representing Full ability to interact and function.
Change from Baseline in PPSv2 at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Does the daily use of PPP001-kit improve the QoL of family caregivers
大体时间：Change from Baseline in CQOLC at Weeks 1 and 4
Changes in Caregivers Quality of Life Index- Cancer (CQOLC). Scale range is 0 to 4; 0 meaning Not at All affected and 4 meaning Very Much affected.
Change from Baseline in CQOLC at Weeks 1 and 4
Changes in validated Udvalg for klinische Undersøgelser (UKU) Side Effects Rating Scale, Self-rating version for Patients (UKU-SERS-Pat)
大体时间：Change versus placebo for safety and tolerability at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months.
Changes in validated Udvalg for klinische Undersøgelser (UKU) Side Effects Rating Scale, Self-rating version for Patients (UKU-SERS-Pat). Scale range is 0 to 3 for rating the degree of severity and a second scale for the investigator that assigns a casual relationship of improbable, possible or probable.
Change versus placebo for safety and tolerability at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months.
Does the daily use of PPP001-kit improve cognition
大体时间：Change versus placebo for Mini-Cog at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Changes in validated Mini-Cog. Scale range is numerical and rates the ability to recall words and ability to draw a clock showing numbers from 1 to 12 and then drawing the given time.
Change versus placebo for Mini-Cog at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Does the daily use of PPP001-kit influence pharmacodynamics
大体时间：Change versus placebo for 100-mm VAS at Weeks 1 and 4
Changes in a 100-mm VAS of good drug effect, and a VAS for the items "high," "relaxed," "stressed," and "happy" (0 = not at all, 10 = extremely)
Change versus placebo for 100-mm VAS at Weeks 1 and 4
Does the daily use of PPP001-kit influence the use of concurrent medications
大体时间：Change from Baseline in MQS version III at Weeks 1 and 4.
Changes in concurrent medications will be measured using the Medication Quantification Scale (MQS) version III. The MQS version III is a method of quantifying different pain drug regimens by evaluating the use of 22 distinct drug classes (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], antidepressants, benzodiazepines, opiates). A single value is calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed.
Change from Baseline in MQS version III at Weeks 1 and 4.
Does the daily use of PPP001-kit improve quality of life
大体时间：Change from Baseline in EQ-5D at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Changes in validated European Quality of Life-5 Dimensions (EQ-5D). First scale range provides 5 statements that describe the participants health TODAY; it includes 5 different health assessments. The second scale is 0 to 100 and requires that the participant places a mark on the scale showing how good or bad they feel TODAY; 0 meaning The worst health they can imagine; 100 meaning the best health they can imagine.
Change from Baseline in EQ-5D at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Does the daily use of PPP001-kit improve uncontrolled cancer pain
大体时间：Change from Baseline in NRS at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Changes in pain as measured by the Numerical Rating Scale (NRS). The NRS is a measure of the average weekly pain intensity score greater than on a 0 to 10 points scale where 0 is No Pain and 10 is the worst pain.
Change from Baseline in NRS at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Does the daily use of PPP001-kit improve mood and illness-understanding
大体时间：Change versus placebo for MDAS at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Changes in validated Memorial Delirium Assessment Scale (MDAS). Scale range is 0 to 3; 0 meaning None and 3 meaning Severe.
Change versus placebo for MDAS at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months
Does the daily use of PPP001-kit influence the use of the need for rescue medication
大体时间：Change from Baseline in rescue medication reported as an MEDD at Weeks 1 and 4.
Rescue medication will be based on the calculation of 10% of the total morphine equivalent daily dose (MEDD). The reduction or increase in the total MEDD will be recorded after starting treatment with PPP001.
Change from Baseline in rescue medication reported as an MEDD at Weeks 1 and 4.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
Tetra Bio-Pharma

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 首席研究员：Antonio Vigano, MD, MSc、McGill University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2018年3月29日

初级完成 (实际的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2018年12月17日

研究完成 (实际的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2019年2月8日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2017年10月17日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2017年11月7日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2017年11月13日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2019年10月9日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2019年10月4日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2019年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • PPP001-Ph3-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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