Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life of patients and a high incidence, with values around 70-90% in advanced and metastatic stages. Than 20 years the main reference for the pharmacological treatment of cancer pain are the guidelines produced by the World Health Organization (WHO). This document shows that the use of opioid drugs is the mainstay of treatment, with particular reference to opioids "major" (3 rd step of the analgesic ladder). The 4 opioids more most commonly prescribed in Italy (oral morphine and oxycodone, fentanyl and buprenorphine transdermal), based on the data currently available, have an analgesic effect would partly overlap but with different percentages of non-responders (NR), a different need to increase the dose over time to maintain adequate analgesia, a different action to the switch to another molecule for ineffectiveness analgesic. The observations described suggest that opioids, although they belong to the same family drug may not be fully comparable with regard to the clinical effects products. Important differences are known on the pharmacokinetic and pharmacodynamic and, more recently, also in terms of pharmacogenomics. This is a comparative study of analgesic strategies based on the use of the 4 mentioned opioids, going to look for possible differences in terms of analgesic efficacy, changes in dose over time, use of switch or permanent abandonment of treatment, parallel to the contour of the side effects. The associated sub-project will link the structure gene of patients and clinical results have emerged.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
518
60 mg /24 ore
25 microg/h
35 microg/h
40 mg /24 ore
Ospedale S. Marta
Catania, Italy, Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Italy, Italy
Istituto Scientifico San Raffaele
Milan, Italy, Italy
Azienda Ospedaliera Valtellina-Valchiavenna
Morbegno, Italy, Italy
Multimedica
Sesto San Giovanni, Italy, Italy
Ospedale Gradenigo
Torino, Italy, Italy
Ospedale Civile di Piacenza
Piacenza, Piacenza, Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera
Reggio Emilia, RE, Italy
Ospedale San Giovanni Battista di Torino
Torino, Torino, Italy
Proportion of Non-Responder (NR) Participants
Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/\< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity "stable" or "worsened" at day 28 compared with baseline values.
Time frame: 28 days
Proportion of Full-responder
Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/\> 30% from visit 6 and visit 1 (NRS 0 to 10).
Time frame: 28 days
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