Clinical trial NCT02293785: GREAT - Good Response With Appropriate Treatment
Official title: GREAT (Good Response With Appropriate Treatment) "Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Pain
Neoplasms
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves a pain longitudinal evaluation in cancer patients through a follow-up of 4 weeks, which will examine in a dynamic clinical, biological and genetic aspects.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnostic (histological or cytological) evidence of locally advanced or metastatic solid tumour;
* With average pain intensity \> 4, measured with NRS and related to the last 24 hours, due to the cancer, requiring OXN for the first time;
* With life expectancy \> one month;
* Strong opioid naïve;
* Eligible to take any of the medications under evaluation;
* With age ≥ 18 years.

Exclusion Criteria:

* With presence of other diseases, including psychiatric/mental illness, severe senile or other form of dementia, that can interfere with participation and compliance with the study protocol or can contraindicate the use of the investigational drugs;
* Diagnosis of primary brain tumor or leukaemia;
* Diagnosis of chronic renal failure;
* Patients with antalgic radiotherapy or radio-metabolic therapy in progress or completed less than 14 days before study;
* Patients starting a first line chemotherapy simultaneously to the beginning of the study;
* Other types of analgesic treatments, including local-regional anesthetic techniques or neurosurgical /ablative methods;
* Patients who cannot guarantee regular follow-up visits for logistic or geographic reasons.

Primary outcomes:
measure: non responders
timeFrame: 28 days
Secondary outcomes:
measure: Opioids Escalation Index
timeFrame: 28 days
measure: additional opioid treatment
timeFrame: 28 days
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Aviano
city: Biella
country: Italy
facility: Ospedale degli Infermi di Biella
city: Cagliari
country: Italy
facility: Ospedale Oncologico A. Businco
city: Genova
country: Italy
facility: E.O. Ospedali Galliera Genova
city: Macerata
country: Italy
facility: Presidio Ospedaliero di Macerata
city: Milano
country: Italy
facility: IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico di Milano
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele
city: Mirano
country: Italy
facility: Ospedale di Mirano
city: Napoli
country: Italy
facility: Ospedale V. Monaldi
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto
city: Piacenza
country: Italy
facility: Ospedale di Piacenza
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
city: Roma
country: Italy
facility: Ospedale San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Umberto I Università Sapienza
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Sondalo
country: Italy
facility: A.O. Valtellina e Valchiavenna
city: Sora
country: Italy
facility: Ospedale SS Trinità - Sora
city: Trapani
country: Italy
facility: Hospice "Raggio di Sole" SPA TP2
Study officials:
References:
citation: Corli O, Montanari M, Greco MT, Brunelli C, Kaasa S, Caraceni A, Apolone G. How to evaluate the effect of pain treatments in cancer patients: results from a longitudinal outcomes and endpoint Italian cohort study. Eur J Pain. 2013 Jul;17(6):858-66. doi: 10.1002/j.1532-2149.2012.00257.x. Epub 2012 Dec 5.