Morphine as First Drug for Cancer Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01541124
First received: January 10, 2012
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Chronic Pain
Drug: Opioid

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Morphine as the First Drug for the Treatment of Cancer Pain

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Analgesic effect [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Enrollment: 60
Study Start Date: August 2008
Study Completion Date: November 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine, Pain intensity
For cancer pain treatment, World Health Organization recomends tritation of opioids associated with non steroidal antiinflamatory drugs. This study compares the analgesic effect with diferents dosages in 63 patients with cancer pain.
Drug: Opioid
10 mg/pill, po, each 6h, during 6m

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01541124

Locations
Brazil
Universidade Federal de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Rioko K Sakata, MD, PhD Universidade Federal de São Paulo
  More Information

No publications provided

Responsible Party: Rioko Kimiko Sakata, Pain Clinic Director, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01541124     History of Changes
Other Study ID Numbers: CEP1133/07
Study First Received: January 10, 2012
Last Updated: February 28, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
cancer pain
analgesia
morphine

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 20, 2014