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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

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

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,246 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

Recent research and studies

clinicaltrials.govStudy

5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial

2024. "5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06232577.

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