Chronic PainNCT01541124
Morphine as First Drug for Cancer Pain
A study testing Opioid in people with Chronic Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Opioid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years, with locally advanced cancer and / or metastases, and pain intensity ≤ 6
Who cannot join
- patients with difficulty maintaining clinical follow-up,
- cognitive impairment and prior treatment with opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morphine as the First Drug for the Treatment of Cancer Pain
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Opioid
- Keywords
- cancer pain, analgesia, morphine
- Medical subject headings
- Chronic Pain, Cancer Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpioidDrug
Also called Morphine
10 mg/pill, po, each 6h, during 6m
| Study group | Role | What they receive |
|---|---|---|
| Morphine, Pain intensity | Experimental | 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. Receives: Drug: Opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rioko Kimiko Sakata, Federal University of São Paulo
- Investigators
- Rioko K Sakata, MD, PhD, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541124
- Sponsor's protocol ID
- CEP1133/07
- Status last verified
- Feb 2012
- First submitted
- 10 Jan 2012
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine as the First Drug for the Treatment of Cancer Pain
- ClinicalTrials.gov ID
- NCT01541124
- Acronym / sponsor ID
- CEP1133/07
- Conditions
- Chronic Pain
- Keywords
- cancer pain, analgesia, morphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morphine, Pain intensity | Experimental | Drug: OpioidFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 18 years, with locally advanced cancer and / or metastases, and pain intensity ≤ 6
Key exclusion criteria (2 listed)
- patients with difficulty maintaining clinical follow-up,
- cognitive impairment and prior treatment with opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OpioidAlso: Morphine10 mg/pill, po, each 6h, during 6m | Drug | Morphine, Pain intensity |
Primary outcome
Analgesic effect
Time frame: 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rioko K Sakata, MD, PhD principal investigator
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid in people with Chronic Pain, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic effect (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.