Back to resultsPEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy (PERFECT FAST)
Primary Purpose
Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain
Status
Withdrawn
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Fentanyl pectin nasal spray (FPNS)
Physician choice-Usual care (PC-UC)
Sponsored by
About this trial
This is an interventional prevention trial for Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain
Eligibility Criteria
Inclusion criteria:
- Male and female aged 18 years or over
- Diagnosis of stage III-IV cancer of oral cavity, oropharynx, hypopharynx, larynx, salivary glands
- Receiving radiation therapy (RT) with or without concurrent platinum based chemotherapy or cetuximab as first line treatment or as postoperative adjuvant treatment
- Background pain controlled with at least 60 mg oral morphine daily or an equianalgesic dose of another opioid. A "background pain controlled" is defined as NRS <4
- Uncontrolled pain during swallowing (predictable BTP at 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)
- Patients able to receive a nasal spray therapy
- Willing and able to sign an informed consent form
- Females with childbearing potential must provide a negative pregnancy test and both males and females must be using adequate contraception during the study
- Patients with PEG or jejunostomy, if are available to take by mouth meals (solid or liquid) or just liquid in order to be compliant with the protocol.
Exclusion Criteria:
- Patients with known metastatic disease
- Known hypersensitivity to opioids, to Fentanyl or to drugs used in the PC-UC, and/or to study medications' formulation ingredients
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
- Patients with moderate to severe respiratory impairment
- Patients with nasogastric feeding tube
- Patients that cannot take FPNS according to investigator's judgment
Sites / Locations
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Istituto per la Ricerca e la Cura del Cancro a carattere Scientifico - IRCC
- Azienda Ospedaliera San luigi di Gonzaga di Orbassano
- Presidio Ospedaliero Mirano Azienda Ulss 13
- Ospedale Sacro Cuore- dona Calabria di Negrar
- Ospedale Bellaria
- Azienda Ospedaliera "Spedali civili" di Brescia
- Ospedale Santa Croce e Carlè
- Azienda Ospedaliera universitaria Careggi
- IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca sul Cancro
- Ospedale Carlo Poma
- Ospedale San Raffaele
- Fondazione IRCCS Istituto Nazionale Tumori
- Istituto Europeo di Oncologia
- Ospedale Niguarda Ca' Granda
- Istituto Nazionale Tumori IRCCS - Fondazione Pascale
- Azienda Ospedaliero Universitaria Pisana
- Istituto Nazionale Tumori Regina Elena
- Policlinico Universitario Gemelli di Roma
- Ospedale Santa Maria della Misericordia
- A.O. Città della Salute e della Scienza - Ospedale Dermatologico S. Lazzaro
- Ospedale di Trento - Presidio Ospedaliero Santa Chiara
- Azienda ULSS 9 Presidio Ospedaliero di Treviso
- Azienda U.L.S.S. 12 Veneziana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PecFent nasal spray
Physician choice-Usual Care (PC-UC)
Arm Description
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: Fentanyl pectin nasal spray (FPNS) 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: Fentanyl pectin nasal spray (FPNS) Physician choice-Usual Care (PC-UC)
Outcomes
Primary Outcome Measures
Difference in the mean intensity of predictable BTP at swallowing from the baseline to 20 minutes after taking FPNS/PC-UC (PID20).
Secondary Outcome Measures
The difference in the mean intensity of predictable BTP at 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 (evaluation of reduction in pain intensity score at each time point: 10,20,30 min after administration of FPNS or PC-UC)
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).
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
Administration of rescue medication (dose and frequency)
Patient's dysphagia assessment. An evaluation of dysphagia by MDADI questionnaire will be performed at baseline and at the end of the study period.
Safety and tolerability
Full Information
NCT ID
NCT01980498
First Posted
October 21, 2013
Last Updated
October 6, 2015
Sponsor
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Collaborators
Consorzio Mario Negri Sud
1. Study Identification
Unique Protocol Identification Number
NCT01980498
Brief Title
PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy
Acronym
PERFECT FAST
Official Title
Multicenter Randomized Open Trial to Evaluate Efficacy of Fentanyl Pectin Nasal Spray vs Physician Choice-Usual Care in Reducing Predictable Breakthrough Pain at Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Collaborators
Consorzio Mario Negri Sud
4. Oversight
5. Study Description
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:
Fentanyl pectin nasal spray (FPNS)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PecFent nasal spray
Arm Type
Experimental
Arm Description
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:
Fentanyl pectin nasal spray (FPNS)
Physician choice-Usual Care (PC-UC)
Arm Title
Physician choice-Usual Care (PC-UC)
Arm Type
Active Comparator
Arm Description
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:
Fentanyl pectin nasal spray (FPNS)
Physician choice-Usual Care (PC-UC)
Intervention Type
Drug
Intervention Name(s)
Fentanyl pectin nasal spray (FPNS)
Intervention Description
The first dose of FPNS will be 100 mcg dose. It will be increased until 800 mcg dose.
Intervention Type
Drug
Intervention Name(s)
Physician choice-Usual care (PC-UC)
Other Intervention Name(s)
PC-UC is any drug used in clinical use for treating IP-BTP
Intervention Description
The PC-UC will be started at a dose according to the physician choice. If this dose of PC-UC is effective on pain control, at the following meal the patient will take the same dose of PC-UC.
If the dose of PC-UC results non effective on pain control, at the following meal the patient will take an increased dose of the same PC-UC drug or change the PC-UC drug, according to the physician choice.
Primary Outcome Measure Information:
Title
Difference in the mean intensity of predictable BTP at swallowing from the baseline to 20 minutes after taking FPNS/PC-UC (PID20).
Time Frame
up to 6 (-1,+2) days
Secondary Outcome Measure Information:
Title
The difference in the mean intensity of predictable BTP at swallowing from the baseline to 10 and 30 minutes after taking FPNS/PC-UC.
Time Frame
up to 6 (-1,+2) days
Title
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)
Time Frame
up to 6 (-1,+2) days
Title
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).
Time Frame
end of study
Title
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
Time Frame
up to 6 (-1,+2) days
Title
Administration of rescue medication (dose and frequency)
Time Frame
up to 6 (-1,+2) days
Title
Patient's dysphagia assessment. An evaluation of dysphagia by MDADI questionnaire will be performed at baseline and at the end of the study period.
Time Frame
day 1 and end of study
Title
Safety and tolerability
Time Frame
up to 6 (-1,+2) days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Male and female aged 18 years or over
Diagnosis of stage III-IV cancer of oral cavity, oropharynx, hypopharynx, larynx, salivary glands
Receiving radiation therapy (RT) with or without concurrent platinum based chemotherapy or cetuximab as first line treatment or as postoperative adjuvant treatment
Background pain controlled with at least 60 mg oral morphine daily or an equianalgesic dose of another opioid. A "background pain controlled" is defined as NRS <4
Uncontrolled pain during swallowing (predictable BTP at 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)
Patients able to receive a nasal spray therapy
Willing and able to sign an informed consent form
Females with childbearing potential must provide a negative pregnancy test and both males and females must be using adequate contraception during the study
Patients with PEG or jejunostomy, if are available to take by mouth meals (solid or liquid) or just liquid in order to be compliant with the protocol.
Exclusion Criteria:
Patients with known metastatic disease
Known hypersensitivity to opioids, to Fentanyl or to drugs used in the PC-UC, and/or to study medications' formulation ingredients
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
Patients with moderate to severe respiratory impairment
Patients with nasogastric feeding tube
Patients that cannot take FPNS according to investigator's judgment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Licitra, MD
Organizational Affiliation
Fondazione IRCCS - Istituto Nazionale Tumori - Milano (Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
City
Meldola
State/Province
Forlì - Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
City
Pesaro
State/Province
Pesaro e Urbino
ZIP/Postal Code
61121
Country
Italy
Facility Name
Istituto per la Ricerca e la Cura del Cancro a carattere Scientifico - IRCC
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Azienda Ospedaliera San luigi di Gonzaga di Orbassano
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Presidio Ospedaliero Mirano Azienda Ulss 13
City
Mirano
State/Province
Venezia
ZIP/Postal Code
30035
Country
Italy
Facility Name
Ospedale Sacro Cuore- dona Calabria di Negrar
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
Ospedale Bellaria
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Azienda Ospedaliera "Spedali civili" di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ospedale Santa Croce e Carlè
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Azienda Ospedaliera universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca sul Cancro
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Carlo Poma
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedale Niguarda Ca' Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Policlinico Universitario Gemelli di Roma
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale Santa Maria della Misericordia
City
Rovigo
ZIP/Postal Code
45100
Country
Italy
Facility Name
A.O. Città della Salute e della Scienza - Ospedale Dermatologico S. Lazzaro
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale di Trento - Presidio Ospedaliero Santa Chiara
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
Azienda ULSS 9 Presidio Ospedaliero di Treviso
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Azienda U.L.S.S. 12 Veneziana
City
Venezia Mestre
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy
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