GREAT - Good Response With Appropriate Treatment

Study Overview
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Brief Summary
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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.

Official Title
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GREAT (Good Response With Appropriate Treatment) Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients

Conditions
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Cancer Pain, Neoplasms

Intervention / Treatment
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* Drug: Oxycodone-Naloxone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxycodone-Naloxone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 28 days |