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

Pain Clinical Trial

Official title:

Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00737191
• Other study ID #: CDR0000588630
• Secondary ID: P30CA015083MCS93
• Status: Withdrawn
• Phase: N/A
• First received: August 15, 2008
• Last updated: March 7, 2012
• Start date: August 2008
• Est. completion date: November 2009

Study information

• Verified date: March 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Drug:
• olanzapine
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-point pain improvement from baseline (0-10 numeric pain rating scale)			No
Secondary	Comparison of active treatment vs placebo			No
Secondary	Effect of olanzapine on opiod adverse effects			No
Secondary	Relationships between endpoints			No