Return to List

Study Summary
No. 2007-0791:.......Cancer Control; Pain......Michael Fisch......Community Oncology
.
Study Summary Title
Study Summary
Number:
2007-0791
Study Title:A Randomized Comparison of Oral Methadone as a "First-Switch" Opioid versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients with Pain Management Problems: The "Simply Rotate" Study
.
Physician New Patient Referral
Name:Michael FischPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Community OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-0276
Contact us about clinical trials
.
General Information
Disease Group:Cancer Control
Pain
Supported By:NCI
Phase of Study:Phase IIReturn
Visit:
Patients will have to be evaluated 3 times by their treating physician
Treatment
Agents:
Methadone
Morphine Sulfate
Oxycodone
Home Care:N/A
Treatment Loc:Both at MDACC & Community Programs (CCOP/Network)
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of the main clinical research study is to compare the effects, good
and/or bad, of methadone to morphine or oxycodone on patients with cancer
pain. The screening and randomization portion of this study will help
researchers to decide if you are eligible to take part in this study and if so,
what medication you will receive.
.
Study Objectives / Outcomes
1.1 Primary Objective
      To compare the effectiveness (i.e. analgesia) of an opioid rotation to oral methadone versus opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone).
1.2 Secondary Objectives
      1.2.1To compare the tolerability of an opioid rotation to oral methadone versus another long-acting opioid switch (sustained release morphine or oxycodone).
      1.2.2 To identify the subset of patients most likely to benefit from an opioid rotation to oral methadone in terms of either significant improvement in pain control or opioid tolerability.
.
Study Status Information
Study Activation / Registration Date:03/10/2009
IRB Review and Approval Date:12/17/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:300
.
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) At least 18 years of age with ongoing care in the outpatient medical oncology setting.

2) Self-reported pain (of any cause) for which one of the following long-acting strong opioids has been prescribed or administered: morphine or oxycodone SR. The physician may utilize short-acting strong or weak opioids at his/her discretion.

3) The oral MEDD of opioids (whether long-acting or immediate-release) is at least 40 mg/day and no greater than 300 mg/day.

4) Worst pain score on a scale of 0 (no pain) to 10 (worst pain) of >/=5 of at least one week's duration based on verbal self-report AND/OR One or more persistently bothersome symptoms attributed to an opioid side effect such as fatigue, confusion, depressed level of consciousness, memory loss, personality change, anorexia, constipation, dehydration, nausea, vomiting, weight loss, pruritus, urticaria, impotence, reduced libido, and urinary retention or hesitancy.

5) Patients may also be receiving systemic anticancer therapy of any kind or bisphosphonates provided that the current therapy was initiated at least 4 weeks prior to study entry.

6) Patients may also be receiving tricyclic antidepressants, NSAIDs, anticonvulsants, and other adjuvant analgesics or psychostimulants provided that the current therapy was initiated at least 2 weeks prior to study entry. Doses of these agents are expected to remain stable until after the first week of opioid rotation. Patients are expected to remain stable until at least the day 8 assessment after initiation of the opioid rotation. Use of the above medications must be documented on the concomitant medication form.

Exclusion Criteria:1) Previous use of the same long acting opioid you are switching to (i.e. the new long acting opioid) within 60 days of study enrollment.

2) Prior methadone therapy within 12 weeks of study entry.

3) Patients receiving methadone maintenance therapy for opioid addiction.

4) Current use of transdermal fentanyl, oxymorphone, or buprenorphine (within 3 days).

5) Current use of intrathecal infusion of analgesics.

6) Radiation therapy or surgical intervention planned within 4 weeks for local control of cancer or pain palliation.

7) Patients with known or suspected cognitive impairment that would probably interfere with adherence to the medication plan or self-report of symptoms and side effects.

8) Any of the following conditions that predispose patients to prolonged QT interval associated tachycardia: • Cocaine abuse within the past 3 months • Serum potassium <3.0 • Concurrent use of antiarrhthmic medications (for example amiodarone or quinidine) • Family history of sudden death • Advanced heart failure (ejection fraction less than 40% and/or NYHA Class III or IV)

9) Pregnant Women – Women of childbearing potential must have negative pregnancy test within 7 days of study registration

.
Links
Registration Number: NCT00726830
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center