NCT06232577

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
8mo left

Started Mar 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

January 22, 2024

Last Update Submit

February 9, 2026

Conditions

Intra-abdominal Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety and adverse events (AEs)

    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

Study Arms (2)

5x-Multiplier Model

EXPERIMENTAL

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: HydrocodoneDrug: TramadolDrug: Oxycodone

3-Tier Model

EXPERIMENTAL

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: HydrocodoneDrug: TramadolDrug: Oxycodone

Interventions

HydrocodoneDRUG

Given by PO

3-Tier Model5x-Multiplier Model
TramadolDRUG

Given by PO

3-Tier Model5x-Multiplier Model
OxycodoneDRUG

Given by PO

Also known as: ETH-Oxydose™ [DSC], OxyContin®, OxyIR®, Roxicodone®
3-Tier Model5x-Multiplier Model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 (on average) during the 30 days prior to consent
  • Participants able to understand and willing to sign an informed consent document
  • English and non-English-speaking participants

You may not qualify if:

  • Participants requiring non-elective (emergent or urgent) surgery will be excluded
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Fields BC, Newhook TE, Lillemoe HA, Qiao W, Karam JA, Matin SF, Meyer LA, Tzeng CD. 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-Abdominal Cancer Surgery: Randomized Clinical Trial Protocol. Adv Cancer Educ Qual Improv. 2025;1(1):19. doi: 10.52519/aceqi.25.1.1.a19.

    PMID: 40583965DERIVED

Related Links

MeSH Terms

Interventions

HydrocodoneTramadolOxycodone

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Ching-Wei D Tzeng, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

March 27, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

US(1)