EUCTR2015-005110-30-IT
Active, not recruiting
Phase 1
A multicenter randomized 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 - FAST RELIEF
ConditionsPatients with head and neck cancer .MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsPECFENT - 100MCG/EROGAZIONE-SPRAY NASALE,SOLUZIONE-USO NASALE-FLACONE(VETRO)-1.55 ML1 FLACONEPECFENT - 400 MCG/EROGAZIONE - SPRAY NASALE, SOLUZIONE - USO NASALE - FLACONE (VETRO) - 1.55 ML 12 FLACONITRAMADOLO MYLAN GENERICS - 100 MG/ML GOCCE ORALI, SOLUZIONE FLACONE DA 10 ML CON CONTAGOCCEORAMORPH - 10 MG/5 ML SOLUZIONE ORALE 20 CONTENITORI MONODOSE 5 MLTACHIDOL - 500 MG/30 MG COMPRESSE RIVESTITTE CON FILM 20 COMPRESSE DIVISIBILI
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with head and neck cancer .
- Sponsor
- FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
- Enrollment
- 158
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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.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.
Outcomes
Primary Outcomes
Not specified
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