The symptoms associated in advanced cancer patients and adverse events due to use of opioids have major influence on the state of health and quality of life of patients. The pain, in particular, is a symptom with severe negative impact and with a prevalence ranging between 33% and 64%, according to the stage of the disease, with values around 70-90% in advanced stages and metastatic. The use of opioids, however, is usually associated with the appearance of common adverse events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. Some effects are self-limiting in the time for the appearance of tolerance while others, as constipation persist. Several clinical studies have demonstrated that the association oxycodone-naloxone (OXN), which consists in the union between a molecule agonist and an antagonist of opioid receptors, reduced the constipation in the presence of unchanged analgesic efficacy compared to oxycodone alone.
Study Type
OBSERVATIONAL
Enrollment
200
Ospedale degli Infermi di Biella
Biella, Biella, Italy
IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, Italy
Ospedale Oncologico A. Businco
Cagliari, Italy
E.O. Ospedali Galliera Genova
Genova, Italy
Presidio Ospedaliero di Macerata
Macerata, Italy
IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico di Milano
Milan, Italy
Istituto Scientifico San Raffaele
Milan, Italy
Ospedale di Mirano
Mirano, Italy
Ospedale V. Monaldi
Napoli, Italy
IRCCS Istituto Oncologico Veneto
Padua, Italy
...and 8 more locations
non responders
Subjects will be classified as non-responders (NR) to treatment if between from the first and to last visit during the follow-up will not exhibit a reduction in average pain at least 30% and/or do not reach a final score of ≤ 4 pain points, defined as average pain experienced in the last 24 hours and measured by an 11-point numerical scale from 0 (no pain) to 10 (maximum pain imaginable).
Time frame: 28 days
Opioids Escalation Index
Percentage of subjects that will need during the follow-up an increase in daily opioid dose ≥5%, measured by the OEI% (Opioids Escalation Index). The value of 5% identifies the cut-off between the increases of dose considered normal or high entity.
Time frame: 28 days
additional opioid treatment
Proportion of subjects that will need during the follow-up of an action to "additional" opioid treatment, in addition to the basic treatment programmed, to maintain the analgesic response in the treatment "around the clock".
Time frame: 28 days
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