Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain Clinical Trial
— PERFECT FASTOfficial 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
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ospedale Bellaria | Bologna | |
| Italy | Azienda Ospedaliera "Spedali civili" di Brescia | Brescia | |
| Italy | Istituto per la Ricerca e la Cura del Cancro a carattere Scientifico - IRCC | Candiolo | Torino |
| Italy | Ospedale Santa Croce e Carlè | Cuneo | |
| 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 Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) | Meldola | Forlì - Cesena |
| Italy | Fondazione IRCCS Istituto Nazionale Tumori | Milano | |
| Italy | Istituto Europeo di Oncologia | Milano | |
| Italy | Ospedale Niguarda Ca' Granda | Milano | |
| Italy | Ospedale San Raffaele | Milano | |
| Italy | Presidio Ospedaliero Mirano Azienda Ulss 13 | Mirano | Venezia |
| Italy | Istituto Nazionale Tumori IRCCS - Fondazione Pascale | Napoli | |
| Italy | Ospedale Sacro Cuore- dona Calabria di Negrar | Negrar | Verona |
| Italy | Azienda Ospedaliera San luigi di Gonzaga di Orbassano | Orbassano | Torino |
| Italy | Azienda Ospedaliera Ospedali Riuniti Marche Nord | Pesaro | Pesaro e Urbino |
| 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 | Ospedale di Trento - Presidio Ospedaliero Santa Chiara | Trento | |
| Italy | Azienda ULSS 9 Presidio Ospedaliero di Treviso | Treviso | |
| Italy | Azienda U.L.S.S. 12 Veneziana | Venezia Mestre |
| Lead Sponsor | Collaborator |
|---|---|
| L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. | Consorzio Mario Negri Sud |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | Administration of rescue medication (dose and frequency) | up to 6 (-1,+2) days | No | |
| Secondary | 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 | No | |
| Secondary | Safety and tolerability | up to 6 (-1,+2) days | Yes |