DRKS00024954招募中2 期
PROTREAT-TRIAL PROPHYLACTIC ANTIEMETIC TREATMENT OF OPIOID-INDUCED NAUSEA AND VOMITING (OINV) IN PALLIATIVE CARE: A RANDOMIZED CONTROLLED PHASE II FEASIBILITY TRIAL - ProTreat
niversitätsklinikum Freiburg Klinik für Palliativmedizin0 个研究点目标入组 30 人开始时间: 2022年3月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1.Patients aged =18 years
- •2.Opioid naïve (no opioids intake within last 72 hours) patients in whom opioid therapy (WHO II & III) is started to treat cancer pain;
- •3.Palliative (not curable) cancer pain patients;
- •4.Patients must have a score for nausea on a 0-10 numeric rating scale (NRS) < 3 at screening visit;
- •5.Written informed consent obtained according to international guidelines and local laws;
- •6.Ability of patient to understand nature, importance, and individual consequences of clinical trial;
- •7.Patients must be able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •1.Patient’s death is imminent (judged by the surprise” question of the treating physician or nurse: Would you be surprised if this patient died within the next 7 days?”); If the answer is „no, trial subject cannot participate;
- •2.Participation in the trial considered inappropriate based on the patient's physical, social, psychological, or spiritual condition (judgement of treating physician or nurse);
- •3.Patients receiving antiemetic treatment within the last 72 h before study treatment period
- •4.Patients if they are known to start a treatment causing acute nausea and/or emesis during study period
- •5.Patients with contraindications or hypersensitivity to opioids or palonosetron, fructose, soya, lactose or peanut intolerance;
- •6.Patients unable to take oral medications or patients receiving medication via PEG-tube;
- •7.Patients undergoing dialyses treatment;
- •8.Known or persistent abuse of medication, drugs, or alcohol;
- •9.Current or planned pregnancy, nursing period;
- •10. Patients who are sexually active and unwilling to use highly effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly effective:
- •a) Oral hormonal contraception (‘pill’)
- •b) Dermal hormonal contraception
- •c) Vaginal hormonal contraception (NuvaRing®)
- •d) Contraceptive plaster
- •e) Long-acting injectable contraceptives
- •f) Implants that release progesterone (Implanon®)
- •g) Tubal ligation (female sterilisation)
- •h) Intrauterine devices that release hormones (hormone spiral)
- •i) Double barrier methods
- •This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, and female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).
- •Except: Female patients who are surgically sterilised by hysterectomy or who are expected to be postmenopausal are eligible for this trial. A lack of menstruation of at least 12 months will be considered as a proof to be postmenopausal.
- •Men must agree to use a latex condom during sexual contact with females of childbearing potential while participating in this study even if they have undergone a successful vasectomy.
- •Patients must abstain from donating blood, semen, or sperm during participation in the study.
- •11.Simultaneous participation in any other interventional clinical trial within the last 14 days before the start of this trial; simultaneous participation in registry and diagnostic trials is allowed;
- •12.Patients without legal German language capacity who are unable to understand the nature, significance and consequences of the trial or any other co-existing medical or psychological condition that will preclude participation in the study;
- •13.Persons who are in a relationship of dependence/employment with the sponsor or the investigator will be excluded.
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