GREAT - Good Response With Appropriate Treatment

Completed

• Conditions: Cancer Pain; Neoplasms

• Registration Number: NCT02293785
• Lead Sponsor: Mario Negri Institute for Pharmacological Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-18
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
non responders	28 days	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).

Secondary Outcome Measures

Name	Time	Method
Opioids Escalation Index	28 days	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.
additional opioid treatment	28 days	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".

Trial Locations

Locations (18)

IRCCS Centro di Riferimento Oncologico di Aviano; 🇮🇹 Aviano, Italy

Istituto Scientifico San Raffaele; 🇮🇹 Milano, Italy

E.O. Ospedali Galliera Genova; 🇮🇹 Genova, Italy

Ospedale Oncologico A. Businco; 🇮🇹 Cagliari, Italy

Ospedale di Piacenza; 🇮🇹 Piacenza, Italy

Ospedale degli Infermi di Biella; 🇮🇹 Biella, Italy

IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico di Milano; 🇮🇹 Milano, Italy

Fondazione PTV Policlinico Tor Vergata; 🇮🇹 Roma, Italy

Ospedale di Mirano; 🇮🇹 Mirano, Italy

Policlinico Umberto I; 🇮🇹 Roma, Italy

Presidio Ospedaliero di Macerata; 🇮🇹 Macerata, Italy

Ospedale V. Monaldi; 🇮🇹 Napoli, Italy

IRCCS Istituto Oncologico Veneto; 🇮🇹 Padova, Italy

A.O. Valtellina e Valchiavenna; 🇮🇹 Sondalo, Italy

Policlinico Umberto I Università Sapienza; 🇮🇹 Roma, Italy

Ospedale San Camillo Forlanini; 🇮🇹 Roma, Italy

Hospice "Raggio di Sole" SPA TP2; 🇮🇹 Trapani, Italy

Ospedale SS Trinità - Sora; 🇮🇹 Sora, Italy