2024-518917-24-00招募中2 期
Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BELCANTO)
Universitaetsklinikum Schleswig-Holstein AöR5 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年11月4日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 5
- 主要终点
- Change of symptoms as change of the ESAS-TSDS-rating after 12+/- days in comparison to baseline between the intervention-group and placebo-group.
研究概览
简要总结
Proof of improvement of global symptom-burden in comparison to placebo-controlgroup in a timeframe of 12 +/- days, measured by a comparison of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) –rating at the time of study-start and after 12 +/- 2 days. The results of the clinical trial shall generate evidence for the use of Cannabisextract Avextra 10/10 solution in palliative oncology an das a basis for planning future trials in this field.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •25 years or older and legally able
- •palliative-oncological therapy
- •ECOG status 1, 2 or 3, unable to work
- •Nutritional Risk Screening ≥ 3
- •Pain numerical rating scale ≥ 4
- •informed consent
- •if WOCBP: negative pregnancytest, safe contraception (Pearl Index < 1%)
- •ESAS TSDS (item 1-8) ≥ 16
排除标准
- •Sickness ≥ grade 3 (CTCAE) or vomitting ≥ grad 2 (CTCAE) in preceding week (exclusioncriterium only)
- •Disability to understand and fill out the questionaires
- •Use of cannabis in the last 6 months
- •alcoholaddiction
- •pregnancy/ breastfeeding
- •contraindicationen or intolerance of IMP
- •bloodpressure systolic <100 mgHg or diastolic <60 mmHg
- •simultaneous participation in other clinical trials; participation in non-interventional trials is in general allowed
- •Any other condition due to judgement of investigator (i.e. Non-Compliance)
结局指标
主要结局
Change of symptoms as change of the ESAS-TSDS-rating after 12+/- days in comparison to baseline between the intervention-group and placebo-group.
Change of symptoms as change of the ESAS-TSDS-rating after 12+/- days in comparison to baseline between the intervention-group and placebo-group.
次要结局
- Global Patient’s Assessment (GPA)
- Absolute and relative change the opioid-dosage (prescribed independently according to standard of care/ freedom of therapy) as morphin-aequivalent-dosing in the course of the trial between the groups (interventional and placebo-group) )
- Change in count and defined daily dosage (DDD) of other analgetic drugs (direct or indirect) like NSAID, Glucocorticoids, neuropharmaceutics at the timepoint of capture in comparison to baseline between the groupsbaseline)
- Symptomchange (change of ESAS-TSDS-rating) at the timepoints of capture in comparison to baseline between the groupsvs. baseline) Change disappetence (timepoints vs. baseline) Change NCCN-Distress-Thermometer (timepoints vs. baseline)
- Change disappetence (visual analog-scale) at the timepoints of capture in comparison to baseline between the groups
- Changeof NCCN-Distress-Thermometer at the timepoint sof capture in comparison to baseline between the groups
- Change of pain (numerical rating scale) at the timeppoints of capturte in comparsion to baselin between the groups
- Change of quality of sleep (Pittsburgh sleepauality index, PSQI) at the timepoints of capture in comparison to bseline betweent he groups
- Change of the result of an Quality-Of-Life-Questionaire (European Organsation for Research and Treatment of Cancer Quality of Life Palliativ, EORTC QLQ-C15 PAL) at the timepoints of capture in comparison to baseline and between the groups
- Appearence, frequence and severity of Adverse Events (AE) coded according to Medical Dictionalry for Regulatory Activities (MeDRA) and evaluated follwing NCI Common Terminology Criteria for Adverse Events (CTCAE) and and comparison between the groups
- Absolute value and change of plasmaconcentration of C-reacive protein (CRP) in comparison to baseline between the groups (derived from routine samples according to standard-of-care).
- Stratified evaluation of the analyses named above, according to kind and stadium of the oncological disease (ICD-10), way of treatment, sex, weight, high-/low-dose and age.
研究者
Prof. Thomas Herdegen
Scientific
Universitaetsklinikum Schleswig-Holstein AöR
研究点 (5)
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