Cancer PainNCT02293785
GREAT - Good Response With Appropriate Treatment
An observational study of Cancer Pain and Neoplasms, run by Mario Negri Institute for Pharmacological Research at 18 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Neoplasms
- What is being tested?
- Oxycodone-Naloxone
- How many people
- 200 participants
- Where
- 18 sitesItaly
- Study dates
- Nov 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Italy18 sites
IRCCS Centro di Riferimento Oncologico di Aviano
Aviano
Ospedale degli Infermi di Biella
Biella, Biella, 13900
Ospedale Oncologico A. Businco
Cagliari
E.O. Ospedali Galliera Genova
Genova
IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico di Milano
Milan
Istituto Scientifico San Raffaele
Milan
Ospedale di Mirano
Mirano
Ospedale V. Monaldi
Naples
IRCCS Istituto Oncologico Veneto
Padova
Ospedale di Piacenza
Piacenza
Presidio Ospedaliero di Macerata
Province of Macerata
Fondazione PTV Policlinico Tor Vergata
Roma
Ospedale San Camillo Forlanini
Roma
Policlinico Umberto I Università Sapienza
Roma
Policlinico Umberto I
Roma
A.O. Valtellina e Valchiavenna
Sondalo
Ospedale SS Trinità - Sora
Sora
Hospice "Raggio di Sole" SPA TP2
Trapani
About this study
Official title: GREAT (Good Response With Appropriate Treatment) "Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients"
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.
- Conditions
- Cancer Pain, Neoplasms
- Being tested
- Oxycodone-Naloxone
- Medical subject headings
- Cancer Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone-NaloxoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 days
Secondary outcomes (2)
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.
Measured: 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".
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293785
- Sponsor's protocol ID
- DOL-IRFMN-6554
- Status last verified
- Mar 2016
- First submitted
- 13 Nov 2014
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23213042
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GREAT (Good Response With Appropriate Treatment) "Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients"
- ClinicalTrials.gov ID
- NCT02293785
- Acronym / sponsor ID
- DOL-IRFMN-6554
- Conditions
- Cancer Pain, Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone-Naloxone | Drug | – |
Primary outcome
non responders
Time frame: 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).
2 secondary outcomes
Opioids Escalation Index
Time frame: 28 days
additional opioid treatment
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Background: PubMed 23213042Corli 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.
Related trials for Cancer Pain
Recruiting
Ameliorated Pap Tests and Cervical Cancer Screening Participation
Cervical Cancer Screening, Cervical Cancer Screening Methods
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Not yet recruiting
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Neuropathic Pain, Chronic Pain
Not yet recruiting
Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
Breast Cancer Surgery, Breast Cancer Surgery Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain and Neoplasms, run by Mario Negri Institute for Pharmacological Research at 18 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non responders (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02293785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.