SAFETY AND EFFICACY OF PPP001-kit FOR THE UNCONTROLLED PAIN RELIEF IN PATIENTS WITH ADVANCED CANCER: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Uncontrolled cancer pain will be measured using a patient self-administered questionnaire.
研究概览
简要总结
This phase 2 multicenter clinical trial assess the safety and efficacy of inhaled PPP001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 1 year.
详细描述
This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 on uncontrolled cancer pain in patients with symptoms related to advanced incurable cancer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent,
- •Adult male and female patients at least 18 years of age,
- •Subject agreed to follow the protocol,
- •Advanced cancer for which there is no known curative therapy as per investigator's judgement,
- •Patients experiencing at least 2 symptoms related to cancer > 4 on ESAS-r-CS NRS including pain symptom,
- •Life expectancy six weeks or longer with PPS > 50% and PaP Score Group A (30-day survival probability >70%),
- •No cognitive impairment according to Mini-Cog©,
- •The patient is able to perform deep inhalations with FEV1 more than 60%,
- •Ability to read and respond to questions in English,
- •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, If of non-childbearing potential - should be surgically sterile or in a menopausal state,
- •A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.
排除标准
- 未提供
研究组 & 干预措施
inhaled THC/CBD (PPP001)
PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device
干预措施: PPP001 (Drug)
Placebo
Placebo inhalation with a device
干预措施: Placebo (Drug)
结局指标
主要结局
Uncontrolled cancer pain will be measured using a patient self-administered questionnaire.
时间窗: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). items are rated on a scale of 1 (not at all) to 4 (very much). high scores on a symptom scale correlate to increased symptom burden
次要结局
- The overall HRQoL (Health related Quality of Life) of patients with uncontrolled symptoms related to advanced cancer will be measured using a patient self rating questionnaire.(change from baseline in the EORTC-QLQ-C15-PAL overall QoL single-item scale score at Week 4)
- The physical, emotional, and total symptom distress will be measured using a patient self administered questionnaire.(Change from Baseline in ESAS-r-CS at Weeks 1 and 4)
- The palliative performance scale will be scored by a healthcare profesional.(Change from Baseline in PPS at Weeks 1 and 4)
- The satisfaction of family caregivers of patients with advanced cancer will be measured using a caregiver self administered questionnaire.(Change from Baseline in treatment-satisfaction questionnaire at Weeks 1 and 4)
- The distress of patients with advanced cancer will be measured using a patient self-administered questionnaire(Change from Baseline in distress thermometer at Week 4)