Role of Methadone As Co-Opioid Analgesic in Cancer Patients
The Study Drugs:
Methadone and morphine are both designed to block pain receptors (cells that are sensitive
to particular drugs) in your nerves and brain.
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in toss of a coin) to 1 of 2 groups. Participants in Group 1 will stay on morphine only.
Participants in Group 2 will receive morphine plus methadone. You will have an equal chance
(50/50) of being placed in either of the 2 groups. You, the medical staff, and study
researchers will not know which group you have been assigned to. If necessary, your doctor
will be able to find out what group you are in the event of an emergency.
Participants in Group 1 will take 2 doses of "slow-release" morphine by mouth every 12
hours, every day for 15 days (plus or minus 3 days). You will also have access to
"immediate-release" morphine to be used, as needed, for pain. If you need more than 3 of
these immediate-release doses in a 24-hour period, you should call your study doctor.
Participants in Group 2 will take 1 dose of slow-release morphine and 1 dose of methadone by
mouth every 12 hours, every day for 15 days (plus or minus 3 days). You will also have
access to immediate-release morphine to be used, as needed, for pain. If you need more than
3 of these immediate-release doses in a 24-hour period, you should call your study doctor.
You will complete a questionnaire once daily about symptoms and pain you may be
experiencing. It will take about 5 minutes to complete each time.
You will be provided with a drug diary to write down when and how often you take pain
On Days 8 and 15 (plus or minus 3 days) the following test and procedures will be performed:
- You will complete 3 questionnaires about any side effects you may be having. They will
take about 15-20 minutes to complete.
- You will have tests to see how sensitive your skin is.
On Day 15 only (plus or minus 3 days), you will have blood (about 1 teaspoon) drawn to
measure kidney function.
Length of Study:
You will be off-study after Day 15 (plus or minus 3 days). You will be taken off study
early if the disease gets worse or intolerable side effects occur.
This is an investigational study. Methadone and morphine are both FDA approved and
commercially available. Their use together is investigational. Up to 60 patients will take
part in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Patient Objective Response
Patient objective response (OR) defined as a dose escalation index <20.
Day 15 (+/- 3 days)
Sriram Yennurajalingam, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|