Clinical trial · Interventional
Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: An Opioid Titration Order Sheet that allows healthcare providers to adjust the dose and schedule of pain medication may help improve pain treatment for patients with cancer. It is not yet known whether the use of an Opioid Titration Order Sheet is more effective than standard care in treating pain caused by cancer. PURPOSE: This randomized phase III trial is studying an Opioid Titration Order Sheet to see how well it works compared with standard care in treating patients with cancer pain.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| educational intervention | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| Titrated pain management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- Standard pain control drugs.
- interventionNames
- Other: educational intervention
- Other: questionnaire administration
- type
- EXPERIMENTAL
- label
- Opioid Titration
- description
- Pain will be Monitored and Medication Titrated
- interventionNames
- Other: educational intervention
- Other: Titrated pain management
- Other: questionnaire administration
Primary outcomes (3)
- measure
- Pain Intensity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed carcinoma
* Cancer-related pain requiring fixed-dose opioid therapy
* Has received ≥ 1 week of fixed-dose opioid therapy AND meets any of the following criteria:
* Inadequate pain control as defined by the patient
* Requires 2 or more rescue doses per day
* Requires adjustments in pain regimen (either fixed or breakthrough dosing)
* No pain crisis that requires hospitalization or immediate anesthetic or neurosurgical intervention
* No predominantly neuropathic pain (e.g., peripheral neuropathy) as assessed by the treating physician
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* ANC \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Serum bilirubin \< 1.5 mg/dL
* Serum creatinine \< 2.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Nutritional, pulmonary, and cardiac status must be considered adequate to tolerate the proposed study therapy
* Must be available for active follow-up
* No documented active psychiatric disorder (i.e., psychosis or major depression) that would preclude informed consent or the patient's ability to comply with study procedures
* No significant infection
* No concerns about compliance with medication regimens or medical follow-up
* No excessive alcohol use
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Concurrent chemotherapy or radiotherapy allowedReferences
Publications (0)
Data not yet available