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Antipsychotic

Olanzapine vs Megestrol Acetate for Cancer-Related Anorexia

Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 14 days prior to registration is required
No symptomatic leptomeningeal disease or known brain metastases as these patients may have difficulty taking oral medications
Must not have
Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
Patients who cannot swallow oral formulations of the agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 4 weeks
Awards & highlights

Summary

This trial compares the effects of olanzapine and megestrol acetate in treating cancer-related loss of appetite.

Who is the study for?
Adults with advanced cancer experiencing loss of appetite or weight loss, who haven't used olanzapine for other conditions or certain appetite stimulants recently. Participants must not have severe diabetes, heart failure, hypertension, a history of blood clots, brain metastases causing symptoms, digestive obstructions or persistent vomiting. They should be able to swallow pills and not have infections like HIV that could complicate the trial.Check my eligibility
What is being tested?
This phase III trial is testing whether olanzapine is more effective than megestrol acetate in increasing appetite and preventing weight loss in patients with advanced cancer. Patients will either receive olanzapine or megestrol acetate and their appetites will be monitored through questionnaires.See study design
What are the potential side effects?
Olanzapine may cause drowsiness, increased appetite leading to weight gain, dry mouth, constipation, restlessness and potential metabolic changes. Megestrol acetate can lead to increased fat accumulation at various body sites (lipodystrophy), blood clots risk increase (thromboembolic phenomena), fluid retention and possible effects on hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.
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I do not have brain metastases or leptomeningeal disease.
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I am not currently taking olanzapine for any condition.
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My blood pressure and heart failure are well-managed.
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I am 18 years old or older.
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I have never had a blood clot.
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My diabetes is well-managed.
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My cancer is in an advanced stage.
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I have lost at least 5 pounds in the last 2 months or eat less than 20 calories/kg of body weight daily.
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I can take care of myself and am up and about more than half of my waking hours.
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I do not have blockages in my digestive tract, issues absorbing food, or severe vomiting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am capable of making my own health decisions.
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I cannot swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in appetite
Secondary outcome measures
Change in well-being status and cachexia/anorexia symptoms
Proportion of patients who report a 5% or greater weight gain

Side effects data

From 2008 Phase 4 trial • 25 Patients • NCT00001656
31%
Hypersalivation
31%
Increased appetite
17%
tachycardia >100 beats/min (supine)
15%
Somnolence
15%
Constipation
9%
Hypertension
8%
Insomnia
8%
Enuresis
8%
Abnormal white blood count
8%
Difficulty concentrating
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olanzapine Group
Clozapine Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (olanzapine)Experimental Treatment2 Interventions
Patients receive olanzapine PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (megestrol acetate)Active Control2 Interventions
Patients receive megestrol acetate PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olanzapine
2005
Completed Phase 4
~5480

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for blood cancers, such as chemotherapy, targeted therapy, and immunotherapy, work through various mechanisms to eliminate cancer cells. Chemotherapy uses cytotoxic agents to kill rapidly dividing cells, including cancer cells. Targeted therapies, like tyrosine kinase inhibitors, block specific molecules involved in cancer cell growth and survival. Immunotherapy harnesses the body's immune system to recognize and destroy cancer cells. These treatments are crucial for blood cancer patients as they directly target the malignancy, aiming to achieve remission or cure. Additionally, supportive care treatments, such as olanzapine for appetite stimulation, are essential to manage symptoms and improve the quality of life during treatment.
Stress Granules in the Anti-Cancer Medications Mechanism of Action: A Systematic Scoping Review.

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,266 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,041 Total Patients Enrolled
2 Trials studying Blood Cancers
110 Patients Enrolled for Blood Cancers
Aminah Jatoi, MDStudy ChairMayo Clinic
28 Previous Clinical Trials
2,377 Total Patients Enrolled

Media Library

Olanzapine (Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT04939090 — Phase 3
Blood Cancers Research Study Groups: Arm I (olanzapine), Arm II (megestrol acetate)
Blood Cancers Clinical Trial 2023: Olanzapine Highlights & Side Effects. Trial Name: NCT04939090 — Phase 3
Olanzapine (Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04939090 — Phase 3
~148 spots leftby May 2026