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

Primary Purpose

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

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

olanzapine

placebo

About this trial

This is an interventional supportive care trial for Hematopoietic/Lymphoid Cancer focused on measuring unspecified adult solid tumor, protocol specific, hematopoietic/lymphoid cancer, pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of active treatment vs placebo

Effect of olanzapine on opiod adverse effects

Relationships between endpoints

Full Information

NCT ID

NCT00737191

First Posted

August 15, 2008

Last Updated

March 7, 2012

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00737191

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Withdrawn

Why Stopped

No accrual; No patients enrolled

Study Start Date

August 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm II

Arm Type

Experimental

Arm Description

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

Arm Title

Arm III

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

olanzapine

Intervention Description

Given orally

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

Given orally

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Comparison of active treatment vs placebo

Title

Effect of olanzapine on opiod adverse effects

Title

Relationships between endpoints

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric E. Prommer, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

12. IPD Sharing Statement

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

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