Early strong opiod treatment in cancer pain -Morphine vs weak opiods - ESOT-M

Conditions: Tumor Pain, mild-moderate intensity (VAS 3-7)
MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-024298-37-IT

Lead Sponsor: Dipartimento Integrato di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Age >=18 years, both male and female • Patients with (solid or hematologic) cancer, at any stage of the disease • Patients able to take oral medications • Patients with mild-moderate average daily pain during the previous 24 hours, ie between 3 and 7 measured using a Numerical Rating Scale (NRS) to 11 levels (0-10) • Opioid-naïve patients, ie patients who at inclusion in the study are not receiving opioid analgesics or who do not receive chronic opioid analgesics around the clock • Patients with life expectancy greater than 3 months • Patients with good performance status (Karnofsky = 60) • Patients who, in the opinion of the clinician, ensure ''compliance'' to the protocol for cognitive performace and lack of psychiatric illness • Patients who give written informed consent for participation
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Chronic renal failure, grade 4 or 5 • Severe hepatic impairment • Severe respiratory insufficiency • Patients with malabsorption syndrome • Patients with diarrhea and/or nausea and vomiting due to specific cancer treatments • Patients with sub-ileus or bowel obstruction for whom oral opioids are not indicated • Contraindications to the use of any type of opioid drugs • Patients at inclusion are following a course of radiotherapy or radioiodine therapy to obtain pain relief, or for whom such treatment was completed less than 14 days or is planned in the next 4 weeks • Inclusion in other experimental studies