Morphine as First Drug for Cancer Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Opioid
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring cancer pain, analgesia, morphine
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
Sites / Locations
- Universidade Federal de São Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Morphine, Pain intensity
Arm Description
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.
Outcomes
Primary Outcome Measures
Analgesic effect
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01541124
First Posted
January 10, 2012
Last Updated
February 6, 2018
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01541124
Brief Title
Morphine as First Drug for Cancer Pain
Official Title
Morphine as the First Drug for the Treatment of Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
cancer pain, analgesia, morphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morphine, Pain intensity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Opioid
Other Intervention Name(s)
Morphine
Intervention Description
10 mg/pill, po, each 6h, during 6m
Primary Outcome Measure Information:
Title
Analgesic effect
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rioko K Sakata, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
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Morphine as First Drug for Cancer Pain
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