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

Mayo Clinic

Status

Withdrawn

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Hematopoietic/Lymphoid Cancer

Pain

Treatments

Other: placebo

Drug: olanzapine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00737191

P30CA015083 (U.S. NIH Grant/Contract)

MCS930 (Other Identifier)

CDR0000588630

07-007571 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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