Tumor Pain, mild-moderate intensity (VAS 3-7) MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Morphine
Concentration unit: mg milligram(s)
Concentration number: 30-
Pharmaceutical Form: Tablet
INN or Proposed INN: Tramadol
Concentration unit: m
Sponsors
Dipartimento Integrato di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to obtain definitive and scientifically valid information about a very common clinical practice in cancer pain management such as early use of strong opioid analgesics, comparing this treatment with that of the second step of WHO analgesic ladder (weak opioids). This objective is achieved by evaluating the rate of responders to each treatment, ie the rate of patients that show a 20% difference in average pain intensity, measured on a 0 to 10 scale, comparing the baseline score with the score at day 28 for each study arm.;Secondary Objective: The secondary objective of the study is to integrate information on the effectiveness of two treatments by evaluating: changes in the dosage of drugs administered, the use of rescue therapies and/or adjuvant drugs, the possible occurrence of serious adverse events, the symptoms measured by the total scale ESAS, the discontinuation for inefficacy or toxicity.;Primary end point(s): The primary end-point of the study is the difference of the proportion of responders to treatment, comparing patients treated with morphine at low doses (step III WHO) and those treated with weak opioids (step II WHO). | — |
Countries
Italy
Outcome results
None listed