Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background PainPhase 3PERFECT FASTNCT01980498

PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy

A Phase 3 study testing Fentanyl pectin nasal spray (FPNS) in people with Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain, run by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. at 25 sites in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain
What is being tested?: Fentanyl pectin nasal spray (FPNS)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 25 sitesItaly
Study dates: Sep 2014to Sep 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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.

Who cannot join

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:
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

Show all 10Show fewer

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

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

Italy25 sites

Ospedale Bellaria
Bologna, Bologna, 40139
Azienda Ospedaliera "Spedali civili" di Brescia
Brescia, Brescia, 25123
Istituto per la Ricerca e la Cura del Cancro a carattere Scientifico - IRCC
Candiolo, Torino, 10060
Ospedale Santa Croce e Carlè
Cuneo, Cuneo, 12100
Azienda Ospedaliera universitaria Careggi
Florence, Firenze, 50134
IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca sul Cancro
Genova, Genova, 16132
Ospedale Carlo Poma
Mantua, Mantova, 46100
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, Forlì - Cesena, 47014
Ospedale San Raffaele
Milan, Milano, 20132
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Milano, 20133
Istituto Europeo di Oncologia
Milan, Milano, 20141
Ospedale Niguarda Ca' Granda
Milan, Milano, 20162
Presidio Ospedaliero Mirano Azienda Ulss 13
Mirano, Venezia, 30035
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Naples, Napoli, 80131
Ospedale Sacro Cuore- dona Calabria di Negrar
Negrar, Verona, 37024
Azienda Ospedaliera San luigi di Gonzaga di Orbassano
Orbassano, Torino, 10043
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, Pesaro e Urbino, 61121
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, 56100
Istituto Nazionale Tumori Regina Elena
Roma, Roma, 00144
Policlinico Universitario Gemelli di Roma
Roma, Roma, 00168
Ospedale Santa Maria della Misericordia
Rovigo, Rovigo, 45100
A.O. Città della Salute e della Scienza - Ospedale Dermatologico S. Lazzaro
Torino, Torino, 10126
Ospedale di Trento - Presidio Ospedaliero Santa Chiara
Trento, Trento, 38122
Azienda ULSS 9 Presidio Ospedaliero di Treviso
Treviso, Treviso, 31100
Azienda U.L.S.S. 12 Veneziana
Venezia Mestre, Venezia Mestre

Other trials in Italy

About this study

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

Read the 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.

Conditions: Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain
Being tested: Fentanyl pectin nasal spray (FPNS), Physician choice-Usual care (PC-UC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fentanyl pectin nasal spray (FPNS)Drug
The first dose of FPNS will be 100 mcg dose. It will be increased until 800 mcg dose.
Physician choice-Usual care (PC-UC)Drug
Also called PC-UC is any drug used in clinical use for treating IP-BTP
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.

Study groups in NCT01980498
Study group	Role	What they receive
PecFent nasal spray	Experimental	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) Receives: Drug: Fentanyl pectin nasal spray (FPNS)
Physician choice-Usual Care (PC-UC)	Active comparator	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) Receives: Drug: Physician choice-Usual care (PC-UC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in the mean intensity of predictable BTP at swallowing from the baseline to 20 minutes after taking FPNS/PC-UC (PID20).
Measured: up to 6 (-1,+2) days

Secondary outcomes (7)

The difference in the mean intensity of predictable BTP at swallowing from the baseline to 10 and 30 minutes after taking FPNS/PC-UC.
Measured: 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)
Measured: 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).
Measured: 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
Measured: up to 6 (-1,+2) days
Administration of rescue medication (dose and frequency)
Measured: up to 6 (-1,+2) days
Patient's dysphagia assessment. An evaluation of dysphagia by MDADI questionnaire will be performed at baseline and at the end of the study period.
Measured: day 1 and end of study
Safety and tolerability
Measured: up to 6 (-1,+2) days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Sep 2015

First posted11 Nov 2013 (estimated)
Study startSep 2014
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01980498
Sponsor's protocol ID: MOLT-2013-02
Other IDs: 2013-001271-20
Acronym: PERFECT FAST
Status last verified: Jun 2014
First submitted: 21 Oct 2013
Last updated: 7 Oct 2015
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01980498
Acronym / sponsor ID: PERFECT FAST / MOLT-2013-02
Conditions: Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.Industry (pharma, biotech, devices)
Collaborators: Consorzio Mario Negri Sud
Study start: Sep 2014
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 11 Nov 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PecFent nasal spray	Experimental	Drug: 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)
Physician choice-Usual Care (PC-UC)	Active comparator	Drug: 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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)

Key exclusion criteria (10 listed)

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:
Pregnant or breastfeeding women
Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fentanyl pectin nasal spray (FPNS)The first dose of FPNS will be 100 mcg dose. It will be increased until 800 mcg dose.	Drug	PecFent nasal spray
Physician choice-Usual care (PC-UC)Also: PC-UC is any drug used in clinical use for treating IP-BTPThe 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.	Drug	Physician choice-Usual Care (PC-UC)

Primary outcome

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

7 secondary outcomes

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
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
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
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
Administration of rescue medication (dose and frequency)
Time frame: up to 6 (-1,+2) days
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
Safety and tolerability
Time frame: up to 6 (-1,+2) days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa Licitra, MD principal investigator

Fondazione IRCCS - Istituto Nazionale Tumori - Milano (Italy)

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01980498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.