Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
CompletedPhase 3NCT00666211
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.
- Conditions
- Brain and Central Nervous System Tumors
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Lymphoproliferative Disorder
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
- Pain
- Precancerous Condition
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Other: educational intervention
- Other: Titrated pain management
- Other: questionnaire administration
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Collaborators
- National Cancer Institute (NCI)
- Start date
- 2005-05
- Primary completion
- 2010-01
- Sex
- All
- Age range
- from 21 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 11
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00666211