NCT03809455撤回2 期
Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- UNICANCER
- 主要终点
- Successful diagnostic or therapeutic examination
研究概览
简要总结
A phase II, prospective, multicentre, single-blinded, randomised study (when fentanyl citrate is used outside of its marketing authorisation) Patients will be enrolled in an observational cohort when the fentanyl citrate is used according to its marketing authorisation.
详细描述
Primary objective (phase II trial):
Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain caused by positional requirements of a diagnostic or therapeutic intervention/examination in cancer patients who do not meet the prescription criteria for fentanyl citrate's marketing authorisation, as follows:
- Patients having received less than 60 mg of slow-release/extended-release morphine.
- Patients having received slow-release/extended-release morphine for less than 7 days.
- Patients who have not received any opioid treatment.
Primary objective (cohort):
Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain caused by positional requirements of a diagnostic or therapeutic intervention/examination in cancer patients when used within the marketing authorisation, as follows:
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
- •Age ≥18 years.
- •Patients in follow up or being treated for cancer.
- •Patients with cancer-related pain (area of pain located near primary tumor or metastatic lesions).
- •not having received any opioid treatment (opioid naïve).
- •or, treated for less than 7 days by a slow-releasing/extend-release opioid treatment; and/or by less than 60 mg per day of oral morphine, or less than 30 mg/day of oral oxycodone, or less than 8 mg/day of oral hydromorphone, or less than 25 µg/h of transdermal fentanyl.
- •Patients need to have at least one of the following interventions, lasting between 25 and 45 minutes during which they will be request to not move:
- •Radiotherapy session*, including tomography (patients hospitalized or treated as outpatients).
- •Dosimetric scanner (hospitalized patients).
- •Positron-emission tomography** (PET): PET-computed tomography [CT] scan and single photon emission computed tomography [SPECT]-CT scan (hospitalized patients).
- •Public health insurance coverage.
- •(*) A patient who has numerous radiotherapy sessions can only be included once; (**) with acquisition phase in a prostrate or decubitus dorsal position and strictly immobile in one of the cameras (PET or SPECT).
- •Inclusion criteria (cohort):
- •As for the inclusion criteria for the phase II study, with the following modifications:
- •Patients treated with a slow-releasing/extended-release opioid for:
- •more than 7 days.
- •and with at least 60 mg per day of oral morphine, or at least 30 mg/day of oral oxycodone, or at least 8 mg/day of oral hydromorphone, or at least 25 µg/h of transdermal fentanyl.
- •Patients who believes that they are cannot assume a prostrate or decubitus dorsal position for a diagnostic or therapeutic examination/intervention due to the pain they will experienced in this position,
- •Patients experience breakthrough pain (numerical pain scale 5), in a region corresponding to the localization of the metastatic lesions or the primary tumor, when they assume a prostrate/decubitus dorsal position,
- •Patients who have breakthrough pain (numerical pain scale 5) in a region corresponding to the localization of the metastatic lesions or the primary tumor that prevents the completion of a diagnostic or therapeutic examination/intervention.
- •Public health insurance coverage.
排除标准
- •Patients with contraindication for the administration of fentanyl citrate: severe respiratory depression or a severe obstructive pulmonary disease.
- •Patients who have already participated in this study.
- •Patients with a history of alcoholism or substance/drug dependence.
- •Patients with an intravenous or subcutaneous opioid patient-controlled analgesic (PCA) pump.
- •Patients unable to communicate or understand instructions in French.
- •Patients deprived of their liberty or under protective custody or guardianship, or unable to provide their consent for study participation.
- •Patients who are pregnant or breast-feeding.
研究组 & 干预措施
FAR Arm
Experimental
干预措施: Fentanyl citrate (Drug)
Placebo Arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Successful diagnostic or therapeutic examination
时间窗: 1 hours after randomization
A patient will be considered a success if the planned immobilization period is completed.
次要结局
未报告次要终点
研究者
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