Status:
COMPLETED
RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Cancer
Cancer Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life of patients and a high incidence, with values around 70-90% in advanced and metastatic stages. Than 20 year...
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 for the first time an analgesic treatment with 3rd step/WHO opioids
- with life expectancy \> one month
- "strong" opioid naïve;
- eligible to take any of the medications under evaluation, by TDS or by mouth;
- with age ≥ 18 years;
Exclusion
- Patients recruited in other researches that conflict or may confound the conduction and results of the present study;
- Lack of informed consent;
- 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;
- with presence of co-morbidities, which could create potentially dangerous drug interactions with opioids (eg, use of macrolide antibiotics or antifungal,….);
- any kind of contraindications to the use of opioid drugs;
- Patients with a known story, past or current, of drugs abuse or addiction;
- Use of drugs which presents a combination of opioids and other molecule (as NSAIDs, paracetamol, naloxone, ..);
- Patients who cannot guarantee regular follow-up visits for logistic or geographic reasons;
- Need of starting 3rd step treatment in an "emergency clinical situation" that do not allow the correct procedures of randomization;
- 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.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT01809106
Start Date
April 1 2011
End Date
October 1 2014
Last Update
December 24 2015
Active Locations (9)
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1
Ospedale S. Marta
Catania, Italy, Italy
2
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Italy, Italy
3
Istituto Scientifico San Raffaele
Milan, Italy, Italy
4
Azienda Ospedaliera Valtellina-Valchiavenna
Morbegno, Italy, Italy