Patients with head and neck cancer undergoing radiotherapy with uncontrolled pain at swallowing (moderate/severe intensity). MedDRA version: 16.0 Level: LLT Classification code 10042648 Term: Swallowing painful System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Pecfent nasal spray
Product Name: PecFent 100mcg
Product Code: not applicable
Pharmaceutical Form: Nasal spray, solution
Trade Name: Pecfent nasal spray
Product Name: PecFent 400mcg
Prod
Sponsors
L. Molteni & C dei F.lli Alitti Società di Esercizio S.p.A.
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of Fentanyl pectin nasal spray (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): The primary efficacy endpoint is the difference in the mean intensity of IP-BTP related to swallowing from the baseline to 20 minutes after taking FPNS/PC-UC (PID20). ;Timepoint(s) of evaluation of this end point: At the first bite/sip of the meal, patients will record the pain intensity (baseline pain) according to an 11-NRS; after this, the patient will take the FPNS/PC-UC and wait 10 minutes before start the meal. Pain intensity related to primary efficacy endpoint will be measured at 20 after drug administration. The intensity of IP-BTP related to swallowing will be measured 3 times a day (at breakfast, lunch and dinner) by NRS for 15 episodes (no more than 3 episodes / day) in 5/6 consecutive days. The mean PID20 across treatment episodes will be used for the analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points 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 ;Timepoint(s) of evaluation of this end point: The secondary efficacy endpoints are: • The difference in the mean intensity of IP-BTP related to swallowing from the baseline to 10 and 30 minutes after taking FPNS/PC-UC. • Time to reach the maximal pain reduction after administration of FPNS/PC-UC (at each time point: 10,20,30 min) • Patient’s pain relief will be measured at the end of the study period through the 5-points numeric scale. • Clinically meaningful pain reduction will be analyzed by assessing percentages of episodes with = 2 point reductions after drug treatment versus baseline • Administration of rescue medication (dose and frequency). • Patient’s dysphagia assessment. An evaluation of disphagia by MDADI questionnaire will be performed at baseline and at the end of the study period. | — |
Countries
Italy
Contacts
Public ContactClinical Trial Manager
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
Outcome results
None listed