Intra-abdominal CancerPhase 2NCT06232577
5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial
A Phase 2 study testing Hydrocodone, Tramadol and Oxycodone in people with Intra-abdominal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-abdominal Cancer
- What is being tested?
- Hydrocodone, Tramadol and Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to 26 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Primary Objectives:
The co-primary objectives of this study are as follows:
- To determine differences in the initial OME prescribed upon discharge between each algorithm/model.
- To determine OME usage by day 14 after hospital discharge.
Secondary Objectives:
Secondary objectives are as follows:
- To determine rates of patients with zero OME upon discharge.
- To determine rates of OME refill requests and completions at 15- and 30-days post-operation.
- To determine number of unused or leftover pills at 15- and 30-days post- operation
- To determine persistent opioid use at 30-days, 3-months, and 6-months post-operation
- To elucidate patient, prescriber, and oncologic factors predictive of persistent opioid use
- To assess quality of life using patient-reported outcomes at 30-days, 3-months, and 6-months post-operation.
- To determine patient satisfaction with either prescribing model.
- Conditions
- Intra-abdominal Cancer
- Being tested
- Hydrocodone, Tramadol, Oxycodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocodoneDrug
Given by PO
TramadolDrug
Given by PO
OxycodoneDrug
Also called ETH-Oxydose™ [DSC], OxyContin®, OxyIR®, Roxicodone®
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hydrocodone; Drug: Tramadol; Drug: 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). Receives: Drug: Hydrocodone; Drug: Tramadol; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start27 Mar 2024
- Primary completion26 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra-abdominal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Wei D Tzeng, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232577
- Sponsor's protocol ID
- 2023-0818
- Other IDs
- NCI-2024-00632
- Status last verified
- Sep 2026
- First submitted
- 22 Jan 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40583965
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06232577
- Acronym / sponsor ID
- 2023-0818
- Conditions
- Intra-abdominal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 26 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives:
The co-primary objectives of this study are as follows:
- To determine differences in the initial OME prescribed upon discharge between each algorithm/model.
- To determine OME usage by day 14 after hospital discharge.
Secondary Objectives:
Secondary objectives are as follows:
- To determine rates of patients with zero OME upon discharge.
- To determine rates of OME refill requests and completions at 15- and 30-days post-operation.
- To determine number of unused or leftover pills at 15- and 30-days post- operation
- To determine persistent opioid use at 30-days, 3-months, and 6-months post-operation
- To elucidate patient, prescriber, and oncologic factors predictive of persistent opioid use
- To assess quality of life using patient-reported outcomes at 30-days, 3-months, and 6-months post-operation.
- To determine patient satisfaction with either prescribing model.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5x-Multiplier Model | Experimental | Drug: Hydrocodone, Drug: Tramadol, Drug: OxycodoneIn 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. |
| 3-Tier Model | Experimental | Drug: Hydrocodone, Drug: Tramadol, Drug: OxycodoneThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocodoneGiven by PO | Drug | 3-Tier Model, 5x-Multiplier Model |
| TramadolGiven by PO | Drug | 3-Tier Model, 5x-Multiplier Model |
| OxycodoneAlso: ETH-Oxydose™ [DSC], OxyContin®, OxyIR®, Roxicodone®Given by PO | Drug | 3-Tier Model, 5x-Multiplier Model |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 40583965Fields 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.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Wei D Tzeng, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrocodone, Tramadol and Oxycodone in people with Intra-abdominal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.