Multicenter Randomized Open Trial to Evaluate Efficacy of Fentanyl Pectin Nasal Spray vs Physician Choice-Usual Care in Reducing Predictable Breakthrough Pain at Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 25
- 主要终点
- Difference in the mean intensity of predictable BTP at swallowing from the baseline to 20 minutes after taking FPNS/PC-UC (PID20).
研究概览
简要总结
The primary objective of the present phase IIIb study is to assess the efficacy of FPNS compared with Physician Choice-Usual Care (PC-UC) in the reduction of swallowing predictable BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy.
详细描述
Population: In and out patients with head and neck cancer undergoing radiotherapy, regardless of the day of the radiotherapy treatment, with or without chemotherapy and taking at least 60 mg of oral morphine daily or an equianalgesic dose of another opioid to control background pain (background pain controlled is defined as NRS <4) but with uncontrolled pain at swallowing (moderate/severe intensity: ≥ 4 on a NRS 0-10).
Study design: Patients that have signed the ICF and met inclusion and exclusion criteria are randomly assigned 1:1 to receive one of the following predictable BTP at swallowing treatments:
- Fentanyl pectin nasal spray (FPNS)
- Physician choice-Usual Care (PC-UC) Each patient will take the drug no more than 3 episode a day (at main meals: breakfast, lunch and dinner) for 15 episodes in total in 6 (-1, +2) consecutive days. At each episode the patients will record the pain at baseline (before drug administration), and 10, 20 30 minutes after taking FPNS or PC-UC.
At each meal, if the administered dose of FPNS or PC-UC is not adequately effective on pain control, the patient is allowed to take a rescue medication of IRMS after 30 min from FPNS or PC-UC administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 未提供
排除标准
- •Patients with known metastatic disease
- •Known hypersensitivity to opioids, to Fentanyl or to drugs used in the PC-UC, and/or to study medications' formulation ingredients
- •Patients with impaired chemistry laboratory exams, assessed as routine clinical practice before radiotherapy start:
- •a. Hepatic function: i. Total bilirubin > 2 times the upper-normal limit (ULN) ii. Serum transaminase > 5 times ULN b. Renal function: i. Serum creatinine concentration > 2 times ULN
- •Pregnant or breastfeeding women
- •Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
- •Patients planned to receive other investigational treatments during study period
- •Patients with moderate to severe respiratory impairment
- •Patients with nasogastric feeding tube
- •Patients that cannot take FPNS according to investigator's judgment
研究组 & 干预措施
PecFent nasal spray
Patients that have signed the ICF and met inclusion and exclusion criteria are randomly assigned 1:1 to receive one of the following IP-BTP treatments:
- Fentanyl pectin nasal spray (FPNS)
- Physician choice-Usual Care (PC-UC)
干预措施: Fentanyl pectin nasal spray (FPNS) (Drug)
Physician choice-Usual Care (PC-UC)
Patients that have signed the ICF and met inclusion and exclusion criteria are randomly assigned 1:1 to receive one of the following IP-BTP treatments:
- Fentanyl pectin nasal spray (FPNS)
- Physician choice-Usual Care (PC-UC)
干预措施: Physician choice-Usual care (PC-UC) (Drug)
结局指标
主要结局
Difference in the mean intensity of predictable BTP at swallowing from the baseline to 20 minutes after taking FPNS/PC-UC (PID20).
时间窗: up to 6 (-1,+2) days
次要结局
- The difference in the mean intensity of predictable BTP at swallowing from the baseline to 10 and 30 minutes after taking FPNS/PC-UC.(up to 6 (-1,+2) days)
- Time to reach the maximal pain reduction after administration of FPNS/PC-UC (evaluation of reduction in pain intensity score at each time point: 10,20,30 min after administration of FPNS or PC-UC)(up to 6 (-1,+2) days)
- Patient's swallowing pain relief will be measured at the end of the study period through the 5-points numeric scale (0=none; 4=complete).(end of study)
- Patient's dysphagia assessment. An evaluation of dysphagia by MDADI questionnaire will be performed at baseline and at the end of the study period.(day 1 and end of study)
- Clinically meaningful pain reduction will be analyzed by assessing percentages of episodes with ≥ 2 point reductions after drug treatment versus baseline and after FPNS versus PC-UC(up to 6 (-1,+2) days)
- Administration of rescue medication (dose and frequency)(up to 6 (-1,+2) days)
- Safety and tolerability(up to 6 (-1,+2) days)