Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care: a Randomized Controlled Phase II Feasibility Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of the study design
研究概览
简要总结
Palliative cancer patients with tumor pain often suffer from nausea and vomiting when starting pain therapy with opioids. The objective of the clinical pilot trial is to evaluate the efficacy and tolerability of palonosetron in the prophylactic treatment of opioid-induced nausea and vomiting.
详细描述
Pain is one of the most common and debilitating symptoms in patients with advanced cancer and opioids are the main stay of treatment for cancer pain. However, initiation of opioid-therapy is frequently hindered by OINV. OINV is a highly distressing symptom and can affect medication compliance, enteral absorption, and quality of life.This Phase II feasibility study is conducted to assess the feasibility of the prophylactic antiemetic treatment of OINV with palonosetron in comparison to placebo. The objective is to investigate the feasibility of patient recruitment and implementation of the study design as well as to obtain an initial estimate of the antiemetic efficacy and safety of prophylactic treatment of OINV with palonosetron compared to placebo. A total of 30 palliative patients starting an opioid-therapy (WHO II & III) for cancer pain will be randomly assigned to receive either a single dose of placebo or palonosetron. Safety and efficiency assessment are based on patient reports regarding OINV, pain and safety parameters during the following 6 days.
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
- Triple (Participant, Care Provider, 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
- •Patients aged ≥18 years
- •Opioid naïve (no opioids intake within last 72 hours) patients in whom opioid therapy (WHO II & III) is started to treat cancer pain;
- •Palliative (not curable) cancer pain patients;
- •Patients must have a score for nausea on a 0-10 numeric rating scale (NRS) < 3 at screening visit;
- •Written informed consent obtained according to international guidelines and local laws;
- •Ability of patient to understand nature, importance, and individual consequences of clinical trial;
- •Patients must be able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •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;
- •Participation in the trial considered inappropriate based on the patient's physical, social, psychological, or spiritual condition (judgement of treating physician or nurse);
- •Patients receiving antiemetic treatment within the last 72 h before study treatment period
- •Patients if they are known to start a treatment causing acute nausea and/or emesis during study period
- •Patients with contraindications or hypersensitivity to opioids or palonosetron, fructose, soya, lactose or peanut intolerance;
- •Patients unable to take oral medications or patients receiving medication via PEG-tube;
- •Patients undergoing dialyses treatment;
- •Known or persistent abuse of medication, drugs, or alcohol;
- •Current or planned pregnancy, nursing period;
- •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:
- •Oral hormonal contraception ('pill')
- •Dermal hormonal contraception
- •Vaginal hormonal contraception (NuvaRing®)
- •Contraceptive plaster
- •Long-acting injectable contraceptives
- •Implants that release progesterone (Implanon®)
- •Tubal ligation (female sterilisation)
- •Intrauterine devices that release hormones (hormone spiral)
- •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.
- •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;
- •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;
- •Persons who are in a relationship of dependence/employment with the sponsor or the investigator will be excluded.
研究组 & 干预措施
Palonosetron Hydrochloride
Palonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO II & III)
干预措施: Palonosetron Hydrochloride (Drug)
Placebo
Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II & III)
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility of the study design
时间窗: 12 months
Rates of patient recruitment per month, screening failures, drop-out from the trial.
Number of patients who show no relevant increase of nausea
时间窗: day 1 to day 6
Number of patients who show no relevant increase of nausea after starting opioid therapy at any of the following 6 days. Nausea scores are assessed on an increasing 11-point numeric rating scale (NRS) from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS). Relevant is an increase on this NRS ≥1, which reflects the minimal clinically important difference (MCID) for nausea
次要结局
- Nausea(day 1 to day 6)
- Rescue anti-emetics(day 1 to day 6)
- Symptom preferences(day1 and day 6)
- Participant's burden by nausea, pain, constipation and headache(day 1 to day 6)
- Severity of constipation(day1 and day 6)
- Complete response of OINV(day 1 to day 6)
- Time to OINV(day 1 to day 6)
- Vomiting(day 1 to day 6)
- Pain control(day 1 to day 6)
- Percentage of participants reporting any grade 3 adverse event (AE) or any serious adverse event (SAE) from patients from the time of the signed ICF to the end of the study.(day 1 to day 6)
- Patient satisfaction with the study drug(day 6)
研究者
Gerhild Becker
Prof. Dr. med.
University Hospital Freiburg