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

NCT ID: NCT00737191

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-11-30

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.

Detailed Description

OBJECTIVES:

• To assess the analgesic effect of olanzapine when administered in combination with opioids in patients with cancer pain.
• To assess the opiod-sparing effect of olanzapine vs placebo.
• To assess the effect of olanzapine on opioid adverse effects.

OUTLINE: Patients undergo opioid titration with a step 3 opioid to maintain a less than 4/10 level of pain (on a 0-10 numeric pain rating scale) to establish a opioid starting dose. When the pain rating increases, patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive oral opioid and oral placebo once daily for 4 weeks.
• Arm II: Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
• Arm III: Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.

Patients undergo quality of life assessments at baseline and three times weekly by questionnaires using a scale from 0-3 and pain assessments periodically by Brief Pain Inventory, Edmonton Symptom Assessment Scale, Linear Analogue Scale Assessments, and Mini-Mental State Examination.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arm I

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

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

Arm II

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

Group Type: EXPERIMENTAL

olanzapine

Intervention Type: DRUG

Given orally

Arm III

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

Group Type: EXPERIMENTAL

olanzapine

Intervention Type: DRUG

Given orally

Interventions

olanzapine

Given orally

Intervention Type: DRUG

placebo

Given orally

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic Cancer Center

Principal Investigators

Eric E. Prommer, MD

Role: STUDY_CHAIR

Mayo Clinic

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCS930

Identifier Type: OTHER

Identifier Source: secondary_id

07-007571

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000588630

Identifier Type: -

Identifier Source: org_study_id