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

March 28, 2024 updated by: M.D. Anderson Cancer Center
To compare 2 different models for prescribing opioid pain medication to provide better pain control to participants with an abdominal cancer who are having surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives:

The co-primary objectives of this study are as follows:

1. To determine differences in the initial OME prescribed upon discharge between each algorithm/model.

1. To determine OME usage by day 14 after hospital discharge.

Secondary Objectives:

Secondary objectives are as follows:

  1. To determine rates of patients with zero OME upon discharge.
  2. To determine rates of OME refill requests and completions at 15- and 30-days post-operation.
  3. To determine number of unused or leftover pills at 15- and 30-days post- operation
  4. To determine persistent opioid use at 30-days, 3-months, and 6-months post-operation
  5. To elucidate patient, prescriber, and oncologic factors predictive of persistent opioid use
  6. To assess quality of life using patient-reported outcomes at 30-days, 3-months, and 6-months post-operation.
  7. To determine patient satisfaction with either prescribing model.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Ching-Wei D Tzeng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants ≥18 years of age
  • Participants undergoing any of the following abdominal surgeries on an elective basis at MD Anderson Cancer Center:
  • Open pancreatectomy
  • Open hepatectomy
  • Open resection of retroperitoneal sarcoma
  • Open nephrectomy
  • Open cytoreductive surgery (in ovarian cancer)
  • Participants with a planned inpatient admission of at least 48 hours after surgery
  • Opioid-naive patients who use less than or equal to 7.5 mg OME per day
  • Participants able to understand and willing to sign an informed consent document
  • English and non-English-speaking participants

Exclusion Criteria:

  • Participants requiring non-elective (emergent or urgent) surgery will be excluded
  • Participants requiring greater than 7.5 mg OME per day (on average) during the 30 days prior to surgery
  • Participants with a current or previous history of substance abuse disorder, including alcohol or drugs
  • Participants prescribed long-acting chronic pain medications
  • Participants using hydromorphone or fentanyl or under the care of a chronic pain specialist
  • Participants unable or unwilling to participate in follow-up study requirements (e.g., QOL surveys, opioid log)
  • Participants discharged on palliative or hospice care
  • Participants with a history of allergic reactions to opioids
  • Participants enrolled in any other opioid discharge protocol
  • Participants who are pregnant
  • Participants who are cognitively impaired

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5x-Multiplier Model
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.
Drug: Hydrocodone
Given by PO
Drug: Oxycodone
Given by PO
Other Names:
  • OxyContin®
  • Roxicodone®
  • ETH-Oxydose™ [DSC]
  • OxyIR®
Drug: Tramadol
Given by PO
Experimental: 3-Tier Model
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).
Drug: Hydrocodone
Given by PO
Drug: Oxycodone
Given by PO
Other Names:
  • OxyContin®
  • Roxicodone®
  • ETH-Oxydose™ [DSC]
  • OxyIR®
Drug: Tramadol
Given by PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and adverse events (AEs)
Time Frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Ching-Wei D Tzeng, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0818
  • NCI-2024-00632 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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