Status:
COMPLETED
GREAT - Good Response With Appropriate Treatment
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Cancer Pain
Neoplasms
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02293785
Start Date
November 1 2014
End Date
February 1 2016
Last Update
March 21 2016
Active Locations (18)
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1
Ospedale degli Infermi di Biella
Biella, Biella, Italy, 13900
2
IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, Italy
3
Ospedale Oncologico A. Businco
Cagliari, Italy
4
E.O. Ospedali Galliera Genova
Genova, Italy