Clinical trial NCT01541124: Morphine as First Drug for Cancer Pain
Official title: Morphine as the First Drug for the Treatment of Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: cancer pain
analgesia
morphine
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background and Objectives:

The drugs used as recommended by the WHO does not promote pain relief for all patients with cancer pain. The objective of this study was to evaluate the use of morphine as the first drug for the treatment of moderate cancer pain by visual analogue scale in patients with advanced disease and / or metastases, as an alternative to the recommendations of the WHO analgesic ladder advocated. Methods: The patients without opioid therapy with more than 18 years, were randomly divided into two groups. G1 patients received medication according to the analgesic ladder, starting treatment with non-opioid in the first step, the second weak opioid and opioid potent in the third, and G2 received morphine as first analgesic. There was evaluated the efficacy and tolerability of initial use of morphine every 2 weeks for 3 months. Results: The study was performed in 63 patients. The groups had similar demographics.

Detailed description: After approval of the Ethics Committee and signing the consent, a prospective randomized study was performed in patients ≥ 18 years, with locally advanced cancer and / or metastases, and pain intensity ≤ 6. There were excluded patients with difficulty maintaining clinical follow-up, cognitive impairment and prior treatment with opioids. G1 patients were treated according to the guidelines of the WHO analgesic ladder starting at the first step, with paracetamol 1g each 6 hours, maximum dose of 4 g/ day, in the second, codeine (30 mg each 4 hours , maximum dose 360 mg / day and morphine 10 mg each 4 hours in the third step. Patients in G2 started with morphine 10 mg each 4 hours. Adjuvant drugs have been associated when indicated. According to the intensity of pain the medication was changed according to analgesic ladder in G1 patients and adjusted the dose in G2. The cancer therapy as palliative radiotherapy, chemotherapy or hormone therapy was performed by the oncologist.

There were evaluated: pain intensity every 2 wk. by visual analogue scale (VAS), quality of life every 4 wk. through the brief questionnaire of quality of life of the WHO 19, satisfaction with treatment, physical capacity measured by the index of Eastern Cooperative Oncology Group (ECOG) 20, and the need for additional analgesics. Adverse effects were recorded. The study was considered completed with the patient's death or three months of follow-up.

To calculate the minimum sample size was used the program BioEstat 2.0. There were used as reference means and standard deviations values of study with a similar method 5. Considering a confidence level of 95% study power of 80% of the minimum sample of 30 patients for each group, totaling 60 patients. For the statistical analysis was used GraphPad Prism ®. There was used the Student t test for age, weight, height, chi-square test for patient satisfaction, need for complementation, and adverse effects, and Mann-Whitney test for pain intensity, quality of life and physical capacity. A p value of ≤ 0,05 was considered significant. The resultas were expressed as mean ± DP.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years, with locally advanced cancer and / or metastases, and pain intensity ≤ 6

Exclusion Criteria:

* patients with difficulty maintaining clinical follow-up,
* cognitive impairment and prior treatment with opioids

Primary outcomes:
measure: Analgesic effect
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rioko K Sakata, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: