Methadone Versus Morphine for Cancer-Related Pain - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00573937

Purpose

The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.

Condition	Intervention	Phase
Neoplasms Pain	Drug: Methadone Drug: Morphine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Methadone Versus Morphine for Moderate to Severe Cancer-Related Pain: A Double-Blind Randomized Parallel Group Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

The Primary Outcome Measure is Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment:	1
Study Start Date:	August 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Methadone	Drug: Methadone Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
Active Comparator: Morphine Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.	Drug: Morphine Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573937

Locations

United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Eric E. Prommer, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eric E. Prommer, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00573937 History of Changes
Other Study ID Numbers:	07-003051
Study First Received:	December 12, 2007
Results First Received:	October 4, 2010
Last Updated:	October 4, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Neoplasms
Pain
Methadone
Morphine

Additional relevant MeSH terms:

Neoplasms
Methadone
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
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012