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

NCT ID: NCT01980498

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PecFent nasal spray

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)

Group Type: EXPERIMENTAL

Fentanyl pectin nasal spray (FPNS)

Intervention Type: 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)

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)

Group Type: ACTIVE_COMPARATOR

Physician choice-Usual care (PC-UC)

Intervention Type: 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.

Interventions

Fentanyl pectin nasal spray (FPNS)

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

Intervention Type: DRUG

Physician choice-Usual care (PC-UC)

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.

Intervention Type: DRUG

Other Intervention Names

PC-UC is any drug used in clinical use for treating IP-BTP

Eligibility 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 glands

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 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

5. 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)

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

9. 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

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

8. Patients with nasogastric feeding tube

9. Patients that cannot take FPNS according to investigator's judgment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorzio Mario Negri Sud

OTHER

Sponsor Role: collaborator

L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Licitra, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS - Istituto Nazionale Tumori - Milano (Italy)

Locations

Ospedale Bellaria

Bologna, Bologna, Italy

Azienda Ospedaliera "Spedali civili" di Brescia

Brescia, Brescia, Italy

Ospedale Santa Croce e Carlè

Cuneo, Cuneo, Italy

Azienda Ospedaliera universitaria Careggi

Florence, Firenze, Italy

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

Meldola, Forlì - Cesena, Italy

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

Genova, Genova, Italy

Ospedale Carlo Poma

Mantova, Mantova, Italy

Ospedale San Raffaele

Milan, Milano, Italy

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Milano, Italy

Istituto Europeo di Oncologia

Milan, Milano, Italy

Ospedale Niguarda Ca' Granda

Milan, Milano, Italy

Istituto Nazionale Tumori IRCCS - Fondazione Pascale

Napoli, Napoli, Italy

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Pesaro e Urbino, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Pisa, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Roma, Italy

Policlinico Universitario Gemelli di Roma

Roma, Roma, Italy

Ospedale Santa Maria della Misericordia

Rovigo, Rovigo, Italy

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

Candiolo, Torino, Italy

Azienda Ospedaliera San luigi di Gonzaga di Orbassano

Orbassano, Torino, Italy

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

Torino, Torino, Italy

Ospedale di Trento - Presidio Ospedaliero Santa Chiara

Trento, Trento, Italy

Azienda ULSS 9 Presidio Ospedaliero di Treviso

Treviso, Treviso, Italy

Azienda U.L.S.S. 12 Veneziana

Venezia Mestre, Venezia Mestre, Italy

Presidio Ospedaliero Mirano Azienda Ulss 13

Mirano, Venezia, Italy

Ospedale Sacro Cuore- dona Calabria di Negrar

Negrar, Verona, Italy

Countries

Italy

Other Identifiers

2013-001271-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MOLT-2013-02

Identifier Type: -

Identifier Source: org_study_id