Clinical trial · Interventional
Opioids With or Without Olanzapine in Treating Patients With Moderate to Severe Cancer Pain
Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study
NCT00737191CI-TRIAL-00006432withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accrual; No patients enrolled
Summary
Brief summary (as posted)
RATIONALE: Opioids lessen pain caused by cancer. It is not yet known whether opioids are more effective when given together with or without olanzapine in treating cancer pain. PURPOSE: This randomized clinical trial is studying opioids to see how well they work when given together with or without olanzapine in treating patients with moderate to severe cancer pain.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic/Lymphoid Cancer | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| olanzapine | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive oral opioid and oral placebo once daily for 4 weeks.
- interventionNames
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
- interventionNames
- Drug: olanzapine
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Moderate to severe cancer pain * Pain score ≥ 7/10 (0-10 numeric pain rating scale) * Requires strong opioids (step 3) for pain control or are already on stable doses of step 3 opioids * Opioid induced cognitive dysfunction or cognitive impairment, defined as cognitive disorder not otherwise specified according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) allowed * No nonmalignant pain * If patient has both malignant and nonmalignant pain, eligibility will be determined by the predominant site of pain PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 months * Normal renal function * Not pregnant or nursing * Negative pregnancy test * Must have a telephone * Able to complete patient questionnaires alone or with assistance * No delirium * No hepatic dysfunction * No nursing home patients * No intractable nausea or vomiting * No true allergy or intolerance to opioids * No gastrointestinal pathology that influences absorption of opioids * No drug seeking behavior or recent substance abuse history * No major depression * No respiratory compromise * No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study PRIOR CONCURRENT THERAPY: * More than 1 month since prior radiotherapy, chemotherapy, or radionuclides * More than 1 month since prior bisphosphonates * No prior surgery that influences absorption of opioids * No concurrent therapeutic procedures or treatments that influence pain * No concurrent active radiation or antineoplastic therapies * No concurrent retroviral therapies * No concurrent drugs that interfere with CYP34A, CYP1A2, or CYP2D6 * No concurrent drugs that interfere with morphine metabolism * No concurrent medications that will influence the disposition of morphine or methadone * No other concurrent antiemetics, antianxiety, or neuroleptic agents
References
Publications (0)
Data not yet available
No reference posted for this study.