Phase 3
N=98
Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
Brain and Central Nervous System Tumors · Chronic Myeloproliferative Disorders · Leukemia · Lymphoma · Lymphoproliferative Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00666211 ↗Enrolled (actual)
98
Serious AEs
9.2%
Results posted
Sep 2012
Primary outcome: Primary: Pain Intensity — 5.60; 6.44; 5.11; 5.98 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- educational intervention (Other); Titrated pain management (Other); questionnaire administration (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity |
5.60; 6.44; 5.11; 5.98 | — |
| PRIMARY Pain-related Distress |
3.32; 4.87 | — |
| PRIMARY Pain Duration |
8.40; 11.31 | — |
| SECONDARY Ability to Engage in Activities of Daily Living (ADL) |
2.18; 1.99; 2.14; 2.06; 1.94; 1.91 | — |
| SECONDARY Interference in Daily Life Due to Pain |
4.49; 4.23; 4.25; 4.12; 4.16; 3.48 | — |
| SECONDARY Mood Disturbance |
1.48; 1.21; 1.45; 1.20; 1.37; 1.12 | — |
| SECONDARY Quality of Life |
1.94; 2.11; 2.18; 2.34; 3.02; 3.30 | — |
Summary
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.
Eligibility Criteria
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 allowed
Data sourced from ClinicalTrials.gov (NCT00666211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.