Methadone Versus Morphine for Cancer-Related Pain
Primary Purpose
Neoplasms, Pain
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methadone
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Neoplasms, Pain, Methadone, Morphine
Eligibility Criteria
Inclusion Criteria:
- Must have a telephone
- Age: patient must be 18 years or older and less than 70 years of age
- Life expectancy of 3 months or greater
- No prior use of step-3 opioids (step 2 opioids are allowed)
- Provision of informed consent
- Score of 26 or greater on Mini-Mental Status Exam (MMSE) (to be done by investigator if there is question about mental status)
- Nonmalignant pain will be excluded; however, if the patient has both malignant and nonmalignant pain, entry into the trial will be determined by the predominant site of pain
- Moderate to severe cancer related pain that requires the use of step-3 opioids
- Normal renal function
- There will be no exclusionary criteria based on Karnofsky score
- Must live no more than 1 hour away from clinic
- Patient must have pain severity of 5-7/10 on a 0-10 pain scale
Exclusion Criteria:
- Nursing home patients
- Obvious cognitive dysfunction
- Intractable nausea or vomiting
- A true allergy or intolerance to opioids
- Unstable renal function
- Undergoing therapeutic procedures likely to influence pain during the study period
- Gastrointestinal pathology or surgery that influences absorption of morphine or methadone
- Must not have had treatment with radiotherapy, chemotherapy or radionuclides in the last 30 days
- History of drug seeking behavior
- Respiratory compromise
- Treatment with bisphosphonates within the last month
- Use of MAO inhibitors
- Drugs that interfere with CYP34A or CYP2D6
- Drugs that interfere with morphine metabolism
- Retroviral therapies
- Active radiation or antineoplastic therapies
- Hepatic dysfunction
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- Study will exclude women who are pregnant and/or nursing
- Women who are of child bearing potential must have a negative urine pregnancy test
- Patients with a recent substance abuse history will be excluded
- Patients with major depression will be excluded
Sites / Locations
- Mayo Clinic Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Methadone
Morphine
Arm Description
Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
Outcomes
Primary Outcome Measures
Change in Numeric Pain Scale Score
Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain. Response to treatment is defined as a 33% reduction in pain score from the baseline to the Week 4 pain score.
Secondary Outcome Measures
Change in Numeric Pain Scale Score
Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00573937
Brief Title
Methadone Versus Morphine for Cancer-Related Pain
Official Title
Methadone Versus Morphine for Moderate to Severe Cancer-Related Pain: A Double-Blind Randomized Parallel Group Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual.
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.
Detailed Description
Treatment of cancer pain is based on the World Health Organization (WHO) step ladder approach to the use of analgesic drugs. Medication potency increases at each step of the WHO ladder, from nonopioid (step 1; e.g., aspirin and nonsteroidal anti-inflammatory drugs) through weak opioids (step 2; e.g. codeine) plus a nonopioid to strong opioids (step 3; e.g., morphine) plus a nonopioid analgesic. Morphine is considered the gold standard for the treatment of moderate to severe pain, but this is based on level C criteria. Research has discovered that methadone is a potent opioid that operates at several levels which are important for pain control. The primary aim is to compare morphine versus methadone as a first-line analgesic in patients with moderate to severe cancer pain. Patients will be randomized to receive either oral slow-release morphine (15 mg) every 8 hours and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain or oral methadone 2.5 mg every 8 hours and methadone 2.5 mg every 4 hours as needed for breakthrough pain. Our hypothesis is that methadone will provide equivalent pain control efficacy after 4 weeks of therapy. We postulate that methadone will be as preferable as morphine as an analgesic. We will compare the two drugs via adverse effects and compare stability of analgesia via comparison of the number of breakthrough pain episodes. The study will attempt to establish equivalency of methadone as a first-line analgesic for moderate to severe cancer pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Pain
Keywords
Neoplasms, Pain, Methadone, Morphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methadone
Arm Type
Active Comparator
Arm Description
Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
Intervention Type
Drug
Intervention Name(s)
Methadone
Other Intervention Name(s)
Methadone Hydrochloride, Methadose, Dolophine Hydrochloride
Intervention Description
Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine Sulfate
Intervention Description
Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough pain.
Primary Outcome Measure Information:
Title
Change in Numeric Pain Scale Score
Description
Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain. Response to treatment is defined as a 33% reduction in pain score from the baseline to the Week 4 pain score.
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Change in Numeric Pain Scale Score
Description
Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have a telephone
Age: patient must be 18 years or older and less than 70 years of age
Life expectancy of 3 months or greater
No prior use of step-3 opioids (step 2 opioids are allowed)
Provision of informed consent
Score of 26 or greater on Mini-Mental Status Exam (MMSE) (to be done by investigator if there is question about mental status)
Nonmalignant pain will be excluded; however, if the patient has both malignant and nonmalignant pain, entry into the trial will be determined by the predominant site of pain
Moderate to severe cancer related pain that requires the use of step-3 opioids
Normal renal function
There will be no exclusionary criteria based on Karnofsky score
Must live no more than 1 hour away from clinic
Patient must have pain severity of 5-7/10 on a 0-10 pain scale
Exclusion Criteria:
Nursing home patients
Obvious cognitive dysfunction
Intractable nausea or vomiting
A true allergy or intolerance to opioids
Unstable renal function
Undergoing therapeutic procedures likely to influence pain during the study period
Gastrointestinal pathology or surgery that influences absorption of morphine or methadone
Must not have had treatment with radiotherapy, chemotherapy or radionuclides in the last 30 days
History of drug seeking behavior
Respiratory compromise
Treatment with bisphosphonates within the last month
Use of MAO inhibitors
Drugs that interfere with CYP34A or CYP2D6
Drugs that interfere with morphine metabolism
Retroviral therapies
Active radiation or antineoplastic therapies
Hepatic dysfunction
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Study will exclude women who are pregnant and/or nursing
Women who are of child bearing potential must have a negative urine pregnancy test
Patients with a recent substance abuse history will be excluded
Patients with major depression will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Northfelt, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
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Methadone Versus Morphine for Cancer-Related Pain
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