A multicenter randomized open trial to evaluate the efficacy of fentanyl pectin nasal spray (FPNS) versus Physician Choice (PC) - Usual Care (UC), in reducing incidental predictable breakthrough pain (IP-BTP) at swallowing in patients with head and neck cancer undergoing radiotherapy - PE.R.F.E.C.T. F.A.S.T STUDY PEctin Rapid Fentanil Efficacy Clinical Trial For pAin at Swallowing und

. Molteni & C dei F.lli Alitti Società di Esercizio S.p.A.0 个研究点目标入组 158 人2013年6月14日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Patients with head and neck cancer undergoing radiotherapy with uncontrolled pain at swallowing (moderate/severe intensity).
发起方: . Molteni & C dei F.lli Alitti Società di Esercizio S.p.A.
入组人数: 158
状态: 进行中（未招募）
最后更新: 8年前

暂无简介。

注册库

who.int

开始日期

2013年6月14日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

. Molteni & C dei F.lli Alitti Società di Esercizio S.p.A.

•1\.Male and female aged 18 years or over
•2\.Diagnosis of stage III\-IV cancer of oral cavity, oropharynx, hypopharynx, larynx, salivary gland cancer
•3\.Receiving radiation therapy (RT) with or without concurrent platinum based chemotherapy or cetuximab as first line treatment or as postoperative adjuvant treatment
•4\.Background pain managed with a stable fixed dose of opioid equivalent to 60mg oral morphine daily
•5\.Uncontrolled pain (IP\-BTP) during swallowing with an intensity \=4 on an 11\-point numeric scale (0\=no pain; 10\=worst possible pain). This pain will have to be measured with the ingestion of a solid/liquid food (depending on the ability to swallow or less solid foods of the patient at moment)
•6\.Patients able to receive a nasal spray therapy
•7\.Willing and able to sign an informed consent form
•8\.Females with childbearing potential must provide a negative pregnancy test and both males and females must be using adequate contraception during the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\.Patients with known metastatic disease.
•2\.Known hypersensitivity to opioids, to Fentanyl or to drugs used in the PC\-UC, and/or to study medications’ formulation ingredients.
•3\.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
•4\.Pregnant or breastfeeding women.
•5\.Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.