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Study Summary
No. 2006-0641:.......Advanced Cancers......Sriram Yennurajalingam......Palliative Care & Rehabilitation Medicine
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Study Summary Title
Study Summary
Number:
2006-0641
Study Title:ROLE OF METHADONE AS CO-OPIOID ANALGESIC
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Physician New Patient Referral
Name:Sriram YennurajalingamPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Palliative Care & Rehabilitation MedicineReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6085
Contact us about clinical trials
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General Information
Disease Group:Advanced CancersSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Twice: at Day 8 (+/- 3 days) and 15 (+/- 3 days)
Treatment
Agents:
MethadoneHome Care:Patient will self administer medication at home and if necessary answer
questionnaires via telephone while at home on Day 8.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
None
Description/
Intervention:
The goal of this clinical research study is to learn whether participants
taking low-dose methadone plus morphine have a lower pain score and experience
fewer side effects as participants taking morphine only.
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Study Objectives / Outcomes
Primary Objective

To determine whether the addition of low dose methadone to morphine(in the methadone group) has a lower dose escalation index as compared to the morphine alone(in the morphine group) at Day 15 (+/- 3 days)

Secondary Objectives

To determine whether individuals on the methadone arm have lower pain intensity than the morphine alone arm as demonstrated by a decrease in two points from baseline (+/- 3 days) in their ESAS score at Day 15 (+/- 3 days).

To determine whether the methadone group of experiences fewer opioid induced neurotoxic side effects (including sedation, myoclonus, hallucinations, hyperalgesia and confusion) as compared to the morphine alone group at Day 15 (+/- 3 days).
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Study Status Information
Study Activation / Registration Date:11/13/2007
IRB Review and Approval Date:06/11/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Individual reporting average pain score for the last 24 hours that is at least a 4 on a numerical scale from 0 to 10 (0= no pain, 10=the worst possible pain) with a history of cancer (active or no evidence of disease).

2) Individual is receiving strong opioids (morphine, fentanyl, oxycodone, hydromorphone) for 3 weeks prior to enrollment.

3) Individual requires at least 150 mg of daily morphine equivalent daily dose for cancer pain. Using the formula MEDD = dose X MEDD Factor (App L) it would be follows: morphine: a 24 hour total oral intake (sum of PRN and around the clock doses) of 150 mg or greater would qualify the patient, for fentanyl alone: a 24 hour total transdermal intake of 75mcg/h or greater would qualify the patient, for oxycodone alone: a 24 hour total oral intake of 100 mg or greater would qualify the patient, and for hydromorphone alone: a 24 hour total oral intake of 30 mg/day or greater would qualify the patient.

4) Individual has the ability to receive morphine or methadone orally.

5) Individual has no known allergy of history of severe toxicity to morphine or methadone.

6) Individual has normal cognition defined as normal state of arousal and absence of obvious clinical findings of confusion, memory or concentration deficit.

7) Individual has adequate renal function (creatinine less or equal to 2.0 MG/DL)

8) Individual has a Zubrod performance status of 3 or lower.

9) Individual is willing to sign written informed consent.

10) Individual is 18 years of age or older.

11) Individual on stable doses(on same dose for at least one week) of nonopioid analgesics including NSAIDS, corticosteroids, gabapentin, pregablin or antidepressants prescribed for the purposes of pain control..

Exclusion Criteria:1) Individual is determined incapable of completing the evaluation forms.

2) Individual with clinically evident impaired cognition.

3) Patient with MEDD greator than 600

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Links
Registration Number: NCT00558870
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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