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.
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 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 Criteria:
- 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.