Opioids With or Without Olanzapine in Treating Patients With Moderate to Severe Cancer Pain

NCT00737191 | Withdrawn DMC

• 4 other identifiers: CDR0000588630P30CA015083MCS93007-007571
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Hematopoietic/Lymphoid Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; hematopoietic/lymphoid cancer; pain

Outcome Measures

Primary Outcomes (1)

• Two-point pain improvement from baseline (0-10 numeric pain rating scale)

Secondary Outcomes (3)

• Comparison of active treatment vs placebo

• Effect of olanzapine on opiod adverse effects

• Relationships between endpoints

Study Arms (3)

Arm I

ACTIVE COMPARATOR

Patients receive oral opioid and oral placebo once daily for 4 weeks.

Other: placebo

Arm II

EXPERIMENTAL

Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.

Drug: olanzapine

Arm III

EXPERIMENTAL

Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.

Drug: olanzapine

Interventions

olanzapine DRUG

Given orally

Arm II; Arm III

placebo OTHER

Given orally

Arm I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Hematologic Neoplasms; Pain

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eric E. Prommer, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 9, 2012

Record last verified: 2012-03