GREAT - Good Response With Appropriate Treatment
GREAT (Good Response With Appropriate Treatment) "Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients"
1 other identifier
observational
200
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 13, 2014
CompletedFirst Posted
Study publicly available on registry
November 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 21, 2016
March 1, 2016
1.3 years
November 13, 2014
March 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Opioids Escalation Index
28 days
additional opioid treatment
28 days
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Ospedale degli Infermi di Biella
Biella, Biella, 13900, 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
Ospedale di Piacenza
Piacenza, Italy
Fondazione PTV Policlinico Tor Vergata
Roma, Italy
Ospedale San Camillo Forlanini
Roma, Italy
Policlinico Umberto I Università Sapienza
Roma, Italy
Policlinico Umberto I
Roma, Italy
A.O. Valtellina e Valchiavenna
Sondalo, Italy
Ospedale SS Trinità - Sora
Sora, Italy
Hospice "Raggio di Sole" SPA TP2
Trapani, Italy
Related Publications (1)
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.
PMID: 23213042BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2014
First Posted
November 18, 2014
Study Start
November 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 21, 2016
Record last verified: 2016-03