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

NCT01980498 | Withdrawn Phase 3

• 2 other identifiers: MOLT-2013-022013-001271-20
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 25

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.

Conditions

Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain

Outcome Measures

Primary Outcomes (1)

• 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 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.

  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

• 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

Study Arms (2)

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)

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)

Drug: Physician choice-Usual care (PC-UC)

Interventions

Fentanyl pectin nasal spray (FPNS) DRUG

The first dose of FPNS will be 100 mcg dose. It will be increased until 800 mcg dose.

PecFent nasal spray

Physician choice-Usual care (PC-UC) DRUG

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.

Also known as: PC-UC is any drug used in clinical use for treating IP-BTP

Physician choice-Usual Care (PC-UC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.: lead
• Consorzio Mario Negri Sud: collaborator

Study Sites (25)

Ospedale Bellaria

Bologna, Bologna, 40139, Italy

Location

Azienda Ospedaliera "Spedali civili" di Brescia

Brescia, Brescia, 25123, Italy

Location

Ospedale Santa Croce e Carlè

Cuneo, Cuneo, 12100, Italy

Location

Azienda Ospedaliera universitaria Careggi

Florence, Firenze, 50134, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, Forlì - Cesena, 47014, Italy

Location

IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca sul Cancro

Genova, Genova, 16132, Italy

Location

Ospedale Carlo Poma

Mantova, Mantova, 46100, Italy

Location

Ospedale San Raffaele

Milan, Milano, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Milano, 20133, Italy

Location

Istituto Europeo di Oncologia

Milan, Milano, 20141, Italy

Location

Ospedale Niguarda Ca' Granda

Milan, Milano, 20162, Italy

Location

Istituto Nazionale Tumori IRCCS - Fondazione Pascale

Napoli, Napoli, 80131, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Pesaro e Urbino, 61121, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Pisa, 56100, Italy

Location

Istituto Nazionale Tumori Regina Elena

Roma, Roma, 00144, Italy

Location

Policlinico Universitario Gemelli di Roma

Roma, Roma, 00168, Italy

Location

Ospedale Santa Maria della Misericordia

Rovigo, Rovigo, 45100, Italy

Location

Istituto per la Ricerca e la Cura del Cancro a carattere Scientifico - IRCC

Candiolo, Torino, 10060, Italy

Location

Azienda Ospedaliera San luigi di Gonzaga di Orbassano

Orbassano, Torino, 10043, Italy

Location

A.O. Città della Salute e della Scienza - Ospedale Dermatologico S. Lazzaro

Torino, Torino, 10126, Italy

Location

Ospedale di Trento - Presidio Ospedaliero Santa Chiara

Trento, Trento, 38122, Italy

Location

Azienda ULSS 9 Presidio Ospedaliero di Treviso

Treviso, Treviso, 31100, Italy

Location

Azienda U.L.S.S. 12 Veneziana

Venezia Mestre, Venezia Mestre, Italy

Location

Presidio Ospedaliero Mirano Azienda Ulss 13

Mirano, Venezia, 30035, Italy

Location

Ospedale Sacro Cuore- dona Calabria di Negrar

Negrar, Verona, 37024, Italy

Location

Study Officials

• Lisa Licitra, MD

  Fondazione IRCCS - Istituto Nazionale Tumori - Milano (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: November 11, 2013
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2014-06

Locations

IT (25)