Patients with head and neck cancer . MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: PECFENT - 100MCG/EROGAZIONE-SPRAY NASALE,SOLUZIONE-USO NASALE-FLACONE(VETRO)-1.55 ML1 FLACONE
Product Name: PecFent
Product Code: [PecFent]
Pharmaceutical Form: Nasal spray, solution
INN o
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
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. 6. Patients planned to receive other investigational treatments during study period 7. Patients with moderate to severe respiratory impairment 8. Patients assuming one of the following drug that can interfere with fentanyl: • Monoamine Oxidase Inhibitors, IMAO) • Ritonavir, ketoconazol, Itraconazolo, Troleandomicina, Claritromicina and Nelfinavir • Nasal decongestants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of FPNS compared with Physician Choice-Usual Care (PC-UC) in the management of swallowing IP-BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy.;Secondary Objective: The secondary objectives are the evaluation of the effect of FPNS versus PC-UC in respect to: • 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 assuming FPNS or PC-UC ) • clinically meaningful pain reduction • patient’s pain relief • administration of rescue medication • patient’s dysphagia • safety and tolerability;Primary end point(s): To test difference in the mean intensity of IP-BTP related to swallowing from the baseline to 20 minutes after assuming FPNS or PC-UC (PID20). For primary endpoint, the study will assess pain at swallowing for 15 episodes, no more than 3 episodes for days, collected in 5/6 consecutive days. A two-sided independent-samples Student’s t-test or Mann-Whitney U-test will be used. In case of unbalance between treatment groups, to adjust for potential confounding factors, a multivariate regression model will be carried out.;Timepoint(s) of evaluation of this end point: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference between treatment groups in change in swallowing pain intensity from baseline to each time point (10, 30 minutes) will be analyzed using a model similar to the primary endpoint.; 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); Patient’s pain relief will be measured at the end of the study period through the 5-points numeric scale (0=none; 4=complete).; Administration of rescue medication (dose and frequency).;Timepoint(s) of evaluation of this end point: 18 months; 18 months; 18 months; 18 months | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Fondazione IRCCS Istituto nazionale dei tumori
Outcome results
None listed