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.
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
- Conditions the study is for
- Hematopoietic/Lymphoid Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- 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
- Are there results?
- None posted in the registry
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 group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive oral opioid and oral placebo once daily for 4 weeks. Receives: Other: placebo |
| Arm II | Experimental | Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks. Receives: Drug: olanzapine |
| Arm III | Experimental | Patients 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.
Two-point pain improvement from baseline (0-10 numeric pain rating scale)
Secondary outcomes (3)
Comparison of active treatment vs placebo
Effect of olanzapine on opiod adverse effects
Relationships between endpoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: No accrual; No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic/Lymphoid CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Eric E. Prommer, MD, Study chair, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study
- ClinicalTrials.gov ID
- NCT00737191
- Acronym / sponsor ID
- CDR0000588630
- Keywords
- unspecified adult solid tumor, protocol specific, hematopoietic/lymphoid cancer, pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual; No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Other: placeboPatients receive oral opioid and oral placebo once daily for 4 weeks. |
| Arm II | Experimental | Drug: olanzapinePatients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks. |
| Arm III | Experimental | Drug: olanzapinePatients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olanzapineGiven orally | Drug | Arm II, Arm III |
| placeboGiven orally | Other | Arm I |
Primary outcome
Two-point pain improvement from baseline (0-10 numeric pain rating scale)
3 secondary outcomes
Comparison of active treatment vs placebo
Effect of olanzapine on opiod adverse effects
Relationships between endpoints
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric E. Prommer, MD study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing olanzapine in people with Hematopoietic/Lymphoid Cancer and Pain, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-point pain improvement from baseline (0-10 numeric pain rating scale). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.