PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy
- Conditions
- Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain
- Interventions
- Drug: Physician choice-Usual care (PC-UC)
- Registration Number
- NCT01980498
- Lead Sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
- Brief Summary
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.
- Detailed Description
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:
1. Fentanyl pectin nasal spray (FPNS)
2. 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
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Patients with known metastatic disease
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Known hypersensitivity to opioids, to Fentanyl or to drugs used in the PC-UC, and/or to study medications' formulation ingredients
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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
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Patients with moderate to severe respiratory impairment
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Patients with nasogastric feeding tube
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Patients that cannot take FPNS according to investigator's judgment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physician choice-Usual Care (PC-UC) 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: 1. Fentanyl pectin nasal spray (FPNS) 2. Physician choice-Usual Care (PC-UC) PecFent nasal spray Fentanyl pectin nasal spray (FPNS) 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: 1. Fentanyl pectin nasal spray (FPNS) 2. Physician choice-Usual Care (PC-UC)
- Primary Outcome Measures
Name Time Method Difference in the mean intensity of predictable BTP at swallowing from the baseline to 20 minutes after taking FPNS/PC-UC (PID20). up to 6 (-1,+2) days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (25)
Ospedale Sacro Cuore- dona Calabria di Negrar
🇮🇹Negrar, Verona, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Istituto per la Ricerca e la Cura del Cancro a carattere Scientifico - IRCC
🇮🇹Candiolo, Torino, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Pesaro e Urbino, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
🇮🇹Meldola, Forlì - Cesena, Italy
Azienda Ospedaliera San luigi di Gonzaga di Orbassano
🇮🇹Orbassano, Torino, Italy
Presidio Ospedaliero Mirano Azienda Ulss 13
🇮🇹Mirano, Venezia, Italy
Ospedale Bellaria
🇮🇹Bologna, Italy
Azienda Ospedaliera "Spedali civili" di Brescia
🇮🇹Brescia, Italy
Ospedale Santa Croce e Carlè
🇮🇹Cuneo, Italy
Fondazione IRCCS Istituto Nazionale Tumori
🇮🇹Milano, Italy
Azienda Ospedaliera universitaria Careggi
🇮🇹Firenze, Italy
IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genova, Italy
Ospedale Carlo Poma
🇮🇹Mantova, Italy
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
🇮🇹Napoli, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Ospedale Niguarda Ca' Granda
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Istituto Nazionale Tumori Regina Elena
🇮🇹Roma, Italy
Policlinico Universitario Gemelli di Roma
🇮🇹Roma, Italy
Ospedale Santa Maria della Misericordia
🇮🇹Rovigo, Italy
A.O. Città della Salute e della Scienza - Ospedale Dermatologico S. Lazzaro
🇮🇹Torino, Italy
Azienda ULSS 9 Presidio Ospedaliero di Treviso
🇮🇹Treviso, Italy
Ospedale di Trento - Presidio Ospedaliero Santa Chiara
🇮🇹Trento, Italy
Azienda U.L.S.S. 12 Veneziana
🇮🇹Venezia Mestre, Italy