Status:
TERMINATED
Morphine Versus Methadone As First Line Strong Opioid for Cancer Pain
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Cancer
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Aims: * To determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 12-week treatment period in patients with advanced cancer. ...
Detailed Description
STUDY DRUGS: MORPHINE is recommended as the first choice of strong pain killers by the World Health Organization Pain Relief Guidelines. METHADONE is recommended as the second choice of strong pain ...
Eligibility Criteria
Inclusion
- Patient has pain caused by advanced cancer (local recurrence or metastatic disease)
- Patient reporting average pain score for the last 24 hours is \>/= 4 on a numerical scale from 0 to 10 (0= no pain, 10=the worst possible pain).
- Patient is receiving mild opioids (e.g. propoxyphene, codeine, tramadol, hydrocodone), mixed agonist/antagonist (e.g. buprenorphine) or no opioids.
- Patient requires initiation of strong opioid for cancer pain.
- Patient has the ability to receive morphine or methadone orally.
- Patient has no known allergy or severe toxicity to morphine or morphine-like drugs (e.g. hydromorphone, oxycodone, oxymorphone, codeine, hydrocodone, levorphanol), or methadone or methadone-like drug (e.g. propoxyphene).
- Patient has normal cognition defined as normal state of arousal and absence of obvious clinical findings of confusion, memory or concentration deficit.
- Patient has normal renal function (creatinine and blood urea nitrogen (BUN) within normal limits) \</= 4 weeks of study entry.
- Patient's performance status (ECOG) is 3 or less.
- Patient is willing to sign written informed consent.
- Patient is 18 years of age or older.
- Patient is able to return to clinic for evaluation by physician day 8 , 15 , 29, 57 and 85 ( +/- 3 days) during study period.
Exclusion
- Patient has concurrent strong opioid for cancer pain, such as morphine, hydromorphone, oxycodone, meperidine, fentanyl, oral transmucosal fentanyl citrate (OTFC), sufentanil, methadone, levorphanol, transdermal fentanyl.
- Patient is receiving radiation therapy for pain control.
- Patient is receiving drugs that interacting with methadone, such as (delavirdine, fluconazole, fluvoxamine, bravavir, amprenavir, efavirenz, lopinavir, nelfinavir, nevirapine, carbamazepine, dexamethasone (Patients receiving short term chemotherapy-related doses are permitted) , phenytoin, rifampin, or grapefruit,).
- Patients are determined incapable of completing the evaluation forms.
- Severe hypotension, acute or severe asthma, paralytic ileus, gastrointestinal obstruction, severe respiratory depression.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00634010
Start Date
February 1 2008
End Date
January 1 2015
Last Update
May 9 2016
Active Locations (3)
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1
LBJ General Hospital
Houston, Texas, United States, 77030
2
The Michael E. DeBakey V.A. Medical Center
Houston, Texas, United States, 77030
3
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030