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Arm II for Cancer
Phase 2
Recruiting
Led By Eric Roeland, M.D., FAAHPM, FASCO
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 4, 8, 12 and 12 weeks from baseline
Awards & highlights
Study Summary
This trial tests if olanzapine can help cancer patients with appetite loss, weakness, and fatigue due to cachexia. It targets neurotransmitters to stimulate appetite, restore calories, and improve quality of life.
Who is the study for?
This trial is for adults with advanced, incurable solid tumors like gastric, liver or lung cancer who are experiencing appetite loss. They must be undergoing non-curative cancer therapy and have an ECOG performance status of 0-2. Participants should not be pregnant, must agree to use contraception, and cannot have certain medical conditions or be on conflicting medications.Check my eligibility
What is being tested?
The trial is testing if olanzapine can help manage appetite loss in patients with advanced cancers. It involves comparing the effects of olanzapine against a placebo while also collecting biospecimens and using questionnaires to assess quality of life.See study design
What are the potential side effects?
Olanzapine may cause side effects such as drowsiness, increased appetite leading to weight gain, dry mouth, restlessness, constipation, and potentially changes in blood sugar levels which could affect diabetics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, if available per standard of care
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, if available per standard of care
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in weight
Secondary outcome measures
>5% weight gain comparing olanzapine 2.5mg vs. olanzapine 5mg vs. placebo
CT scan (optional)
Health Care Utilization
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm IIExperimental Treatment4 Interventions
Patients receive a higher dose (5 mg) of olanzapine PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo an optional baseline CT scan and collections of monthly blood samples on study.
Group II: Arm I (olanzapine, optional biospecimen collection)Experimental Treatment4 Interventions
Patients receive a lower (2.5mg) dose of olanzapine orally (PO) nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients can choose to undergo computed tomography (CT) scan at baseline and monthly blood sample collections on study.
Group III: Arm IIIPlacebo Group4 Interventions
ARM III: Patients receive placebo PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo CT scan and monthly collection of blood samples on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olanzapine
2005
Completed Phase 4
~5480
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,663 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
231 Previous Clinical Trials
2,090,597 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
978 Previous Clinical Trials
7,386,354 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition or are planning a procedure that could affect how well the study drug is absorbed in your body. This includes problems with swallowing, mouth sores, stomach surgery, inflammation of the colon, bowel blockage, or having a certain type of surgery that affects digestion.You have other medical or mental health conditions that could make it risky for you to participate in the study. This includes recent thoughts or behaviors of wanting to harm yourself or any abnormal test results that could affect your safety in the study.You have a condition called recurrent ascites, which means you have excess fluid in your abdomen that does not respond to medicine and needs to be drained.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II
- Group 2: Arm III
- Group 3: Arm I (olanzapine, optional biospecimen collection)
Awards:
This trial has 0 awards, including: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.
Has the arm of this clinical trial involving olanzapine and optional biospecimen collection been approved by the FDA?
"With no prior clinical evidence demonstrating efficacy, our team assessed the safety of Arm I (olanzapine with optional biospecimen collection) to be a 2 on a scale from 1-3."
Answered by AI
Is the current research project actively seeking participants?
"According to the information hosted on clinicaltrials.gov, patient recruitment for this trial has concluded as of January 27th 2023. Despite that, there are currently 89 other medical trials actively seeking participants at the moment."
Answered by AI
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