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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 4 weeks
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 4 weeks
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 • NCT0000165631%
Increased appetite
31%
Hypersalivation
17%
tachycardia >100 beats/min (supine)
15%
Somnolence
15%
Constipation
9%
Hypertension
8%
Difficulty concentrating
8%
Insomnia
8%
Enuresis
8%
Abnormal white blood count
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
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,278 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,322 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Aminah Jatoi, MDStudy ChairMayo Clinic
28 Previous Clinical Trials
2,377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am capable of making my own health decisions.I can speak and/or read English or Spanish.I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.I do not have brain metastases or leptomeningeal disease.I am not currently taking olanzapine for any condition.I am concerned about my loss of appetite or weight, and I rate my appetite 4 or worse.My blood pressure and heart failure are well-managed.I am 18 years old or older.I have never had a blood clot.My diabetes is well-managed.I haven't taken any antipsychotic medications like risperidone or clozapine in the last 30 days.My cancer is in an advanced stage.I cannot swallow pills.I have lost at least 5 pounds in the last 2 months or eat less than 20 calories/kg of body weight daily.I haven't taken androgens, progesterone, or appetite stimulants in the last month.I agree to use effective birth control during the study.My cancer is not hormone-sensitive like some breast, endometrial, or prostate cancers.I am concerned about my loss of appetite or weight, and I rated my appetite 4 or worse.I haven't had COVID-19 or any lasting taste issues from it.I can take care of myself and am up and about more than half of my waking hours.I am not on long-term steroids, except for short-term dexamethasone with chemotherapy.I do not have blockages in my digestive tract, issues absorbing food, or severe vomiting.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (olanzapine)
- Group 2: Arm II (megestrol acetate)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the common medical conditions that Olanzapine is used to address?
"Olanzapine is often taken to treat unipolar depression, though it can also alleviate acute coryza, acquired immunodeficiency syndrome, and mental depression."
Answered by AI
Are there any vacancies in this research program for test subjects?
"That is correct, the online clinicaltrials.gov registry shows that this study is still opening to new participants. The first posting was on October 15th, 2021 with a recent update on January 11th, 2022. They are looking for 360 individuals total from 68 different locations."
Answered by AI
Is this the first clinical trial to test Olanzapine's efficacy?
"Olanzapine was first studied in 2007 at VA Puget Sound Health Care System. As of now, there are417 completed trials and 28 live trials. A large portion of these studies are based out of Effingham, Illinois."
Answered by AI
How many participants are sought for this research project?
"To carry out this research properly, 360 individuals who fit the bill are needed. People living near Effingham, Illinois or Lakewood, Colorado can go to Crossroads Cancer Center and Rocky Mountain Cancer Centers-Lakewood respectively to take part in the trial."
Answered by AI
Are there any possible dangers associated with Olanzapine?
"Since this is a Phase 3 trial, there is some data indicating Olanzapine's efficacy and multiple rounds of data supporting its safety, so our team at Power gives it a score of 3."
Answered by AI
Is this a new clinical trial?
"There are twenty-eight ongoing studies involving olanzapine in nine countries and four hundred fourteen cities. The first trial began in 2007 and was sponsored by Eli Lilly and Company. That initial study only involved twenty patients but it completed its drug approval stage. In the years since then, there have been 417 more trials conducted."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
What site did they apply to?
Sanford Joe Lueken Cancer Center
Arizona Center for Cancer Care-Surprise
Arizona Center for Cancer Care - Gilbert
What portion of applicants met pre-screening criteria?
Did not meet criteria
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