Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden (CAPTURE)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Multidimensional assessment of the state of health: Edmonton Symptom Assessment System questionnaire(ESAS)
研究概览
简要总结
CAPTURE is a prospective, interventional, randomized, phase 2, double-blind, placebo-controlled study assessing the therapeutic add-on effect of the balanced THC/CBD extract (Cannabis extract Avextra 10/10 oral solution) on symptom burden in patients with advanced oncological disease receiving active treatment with WHO level II or III opioids and adjuvants therapies, compared to placebo, as measured by the Edmonton Symptom Assessment System Total Symptom Distress Score (ESAS-TSDS) at 8 weeks post randomization.
详细描述
Secondary objectives are: to assess the impact of the therapeutic add-on of a balanced THC/CBD extract (Avextra 10/10 oral solution) compared to placebo, in terms of: nutritional status, sleep quality, neuropathic pain, functional interference, severity of clinical symptoms assessed by ESAS sub scores and ESAS-TSDS response rate at 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 or over
- •No previous use of Cannabis in the last 6 months
- •Patients with advanced oncological neoplasia with a life expectancy of at least 6 months on active antineoplastic treatment and with a compromised quality of life defined by at least one of the following criteria:
- •presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite
- •presence of psychological symptoms, such as anxiety, depression and insomnia
- •ESAS-TSDS score ≥ 16
- •Patients on stable therapy with "Level II" or Level III" opioids according to the WHO analgesic scale and/or with adjuvants
- •Women of childbearing age (Women Of Child Bearing Potential, WOCBP) are eligible for the study only if:
- •Negative pregnancy test
- •Willingness to use effective contraception (concurrent use of two methods with a Pearl Index < 1%) during treatment and for at least 3 months after the last dose of the investigational product.
- •Male participants with partners of childbearing potential must agree to use condoms (with spermicide, if available) in combination with an additional highly effective contraceptive method used by their partner, during treatment period and for at least 3 months after the last dose of the investigational product.
排除标准
- •1. Inability to understand and complete the questionnaires required by the study
- •Known hypersensitivity/allergy to THC or CBD
- •Psychiatric illness related to schizophrenia/psychosis
- •Personal history of any type of addiction
- •Pregnancy / breastfeeding
- •PEG feeding
- •Any other medical condition that, in the opinion of the physician, would affect the participant's safety or ability to comply with the study protocol
- •Concurrent participation in other clinical studies started less than 30 days ago
研究组 & 干预措施
Cannabis extract
balanced THC/CBD extract (Cannabis extract Avextra 10/10 oral solution)
干预措施: Cannabis Extract Oil (Drug)
Placebo
Mixture of fatty oils with components according to the oil monographs of the European Pharmacopoeia with external appearance of the package, color, odor, density of the solution, corresponding to those of the active medicinal drug.
干预措施: Placebo (Other)
结局指标
主要结局
Multidimensional assessment of the state of health: Edmonton Symptom Assessment System questionnaire(ESAS)
时间窗: The ESAS questionnaire will be completed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42) and visit4 (day52) up to 2 months
ESAS-TSDS (Total Symptom Distress Score) is defined as the total score derived from the sum of individual ratings for each of the nine symptoms included in the ESAS questionnaire
次要结局
- NRS -2002 Nutrition Score Risk Screening(The NRS will be assessed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42)up to 2 months)
- Sleep qualit- PSQI questionnaire(The PSQI questionnaire will be completed at baseline, visit2 (day 28) and visit4 (day 56) up to 2 months)
- Neuropathic pain - DN4 questionnaire(The DN4 questionnaire will be completed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42) and visit4 (day52) up to 2 months)
- Cancer-related asthenia - BFI questionnnaire(The BFI questionnaire will be completed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42) and visit4 (day52) up to 2 months)
- Antineoplastic therapies(Antineoplastic drugs are documented at all visits up to 2 months.)
- Concomitant medications(Concomitant medications are documented at all visits up to 2 months)
- adverse events(Adverse events, their severity and relationship to the investigational medicinal product will be documented at all visits (according to the CTC-AE system) up to 2 months)
- treatment compliance(Intake of the investigational drug will be documented at all visits by monitoring the patient's diary up to 2 months)