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Hematopoietic/Lymphoid CancerNCT00737191

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

A study testing olanzapine in people with Hematopoietic/Lymphoid Cancer and Pain, run by Mayo Clinic.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
olanzapine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2008to Nov 2009
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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

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.

Read the 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.

Being tested
olanzapine, placebo
Keywords
unspecified adult solid tumor, protocol specific, hematopoietic/lymphoid cancer, pain
Medical subject headings
Hematologic Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • olanzapineDrug

    Given orally

  • placeboOther

    Given orally

Study groups in NCT00737191
Study groupRoleWhat they receive
Arm IActive comparatorPatients receive oral opioid and oral placebo once daily for 4 weeks.
Receives: Other: placebo
Arm IIExperimentalPatients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
Receives: Drug: olanzapine
Arm IIIExperimentalPatients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.
Receives: Drug: olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)
  1. Comparison of active treatment vs placebo

  2. Effect of olanzapine on opiod adverse effects

  3. Relationships between endpoints

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionNov 2009
  4. Study completionNov 2009

Why it stopped: No accrual; No patients enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00737191
Sponsor's protocol ID
CDR0000588630
Other IDs
P30CA015083, MCS930, 07-007571
Status last verified
Mar 2012
First submitted
15 Aug 2008
Last updated
9 Mar 2012
Results posted
No
Data monitoring committee
Yes

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