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Opioid
5x-Multiplier Model for Cancer
Phase 2
Recruiting
Led By Ching-Wei D Tzeng, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with a planned inpatient admission of at least 48 hours after surgery
Open nephrectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial is comparing two different ways of prescribing opioid pain medication to help patients with abdominal cancer manage pain after surgery.
Who is the study for?
This trial is for adults over 18 who have abdominal cancer and are undergoing specific open surgeries like pancreatectomy or hepatectomy. They must be opioid-naive, using less than or equal to 7.5 mg of opioids daily, and expected to stay in the hospital for at least two days post-surgery. Participants must understand and sign a consent form; both English and non-English speakers can join.Check my eligibility
What is being tested?
The study is testing two methods of prescribing opioid painkillers—Hydrocodone, Tramadol, Oxycodone—after abdominal cancer surgery. The goal is to see which model offers better pain control: the '5x-Multiplier' approach versus the '3-Tier Model'.See study design
What are the potential side effects?
Possible side effects from Hydrocodone, Tramadol, Oxycodone include nausea, vomiting, constipation, drowsiness, dizziness, itching skin reactions and potential dependency or withdrawal symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will be staying in the hospital for at least 2 days after my surgery.
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I have had or will have an open surgery to remove a kidney.
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I have had open surgery to reduce my ovarian cancer.
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I use very little or no opioid pain medication daily.
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I use less than or equal to 7.5 mg of opioids daily.
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I am scheduled for or have had an open surgery on my pancreas.
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I am scheduled for or have had an open liver surgery.
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I had surgery to remove a tumor from behind my abdomen.
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I am 18 years old or older.
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I am scheduled for a specific abdominal surgery at MD Anderson.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and adverse events (AEs)
Trial Design
2Treatment groups
Experimental Treatment
Group I: 5x-Multiplier ModelExperimental Treatment3 Interventions
In this group, you will be given 5 times the amount of opioid medication you needed on your last day in the hospital. You would then use this supply plus standard non-narcotic pain medications.
Group II: 3-Tier ModelExperimental Treatment3 Interventions
The total amount of opioid medication you needed on your last day in the hospital to set a maximum number of opioid medications at discharge (up to 30).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocodone
2016
Completed Phase 4
~27640
Tramadol
2014
Completed Phase 4
~3320
Oxycodone
2014
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,980 Previous Clinical Trials
1,789,693 Total Patients Enrolled
Ching-Wei D Tzeng, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there ongoing efforts to actively enroll patients in this research study?
"According to clinicaltrials.gov, the study posted on 6/30/2024 and last edited on 1/22/2024 is presently not seeking applicants. However, there are currently 10 ongoing trials that are open for enrollment."
Answered by AI
Has the 5x-Multiplier Model received official endorsement from the FDA?
"For the 5x-Multiplier Model, our team at Power rates its safety as a 2 on a scale of 1 to 3. This determination is based on it being in Phase 2 where there exists some evidence backing its safety profile but none demonstrating efficacy yet."
Answered by AI
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