Safety and Efficacy of PPP011-kit for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia: a Randomized, Double Blind, Placebo Controlled, Parallel Group Study
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Cachexia grade will be measured as per Weight Loss Grading System
研究概览
简要总结
A large number of patients with advanced cancer also suffer from cachexia. Cachexia is a syndrome characterized by loss of skeletal muscle mass (with/or without loss of fat mass) that cannot be reversed by nutritional support and progressively leads to functional impairment. Patients who suffer from anorexia and cachexia have lower survival rates. Some patients with cancer use cannabis to improve the way they feel and relieve their pain. However, there is very sparse high-quality research to prove that cannabis products are truly effective. This study will investigate patients with advanced cancer who use inhaled therapeutic cannabinoid-based medication (PPP011), in addition to palliative care management, and will assess if these patients experience improvement in functional status as a surrogate endpoint for survivalquality
详细描述
This is a 12-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP011 on physical functioning and cachexia progression in patients with cachexia 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,
- •Patient agreed to follow the protocol,
- •Advanced cancer for which there is no known curative therapy,
- •The patient has a cachexia weight loss of Grade of 2 or Grade 3 cachexia as follow (based on Weight Loss Grading System) Weight loss accounts for the last 6 months before screening.
- •Patient's weight 6 months before screening must be available
- •Karnofsky Performance Status score ≥ 60 %
- •Life expectancy of at least 4 months, excluding refractory cachexia
- •No cognitive impairment according to Mini-Cog Negative confusion assessment according to CAM,
- •The patient is able to perform deep inhalations with FEV1 more than 60%,
- •Ability to read and respond to questions in French or English or French or Spanish,
- •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 (PPP011)
PPP011 (synthetic THC/CBD) inhalation with mighty medic device
干预措施: PPP011 (Drug)
Placebo
Placebo inhalation with mighty medic device
干预措施: Placebo (Drug)
结局指标
主要结局
Cachexia grade will be measured as per Weight Loss Grading System
时间窗: Change from baseline at week 4, 8 and 12.
Downgrading cachexia grade or grade maintenance will be considered as a drug benefit.
physical functioning related to advanced cancer will be measured using a patient self rating questionnaire.
时间窗: Change from baseline in EORTC-QLQ-C15-PAL physical functioning in multi-item scales at week 4, 8 and 12 W4 W8 W12
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
- pain will be recorded: VAS(Observed and Change from baseline in a VAS on pain AND no increase in pain medications at week 4, 8 and, 12 and 24.)
- Patient nutritional and functional assessment will be meseared using a patient self rating questionnaire(Observed and change from baseline in patient nutritional and functional assessment (PG-SGA) at baseline and week 4, 8 and, 12.)