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Arm I (olanzapine, optional biospecimen collection) for Cancer
Phase 2
Waitlist Available
Led By Eric Roeland, M.D., FAAHPM
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 2, 4, and 6 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2, 4, and 6 weeks from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2, 4, and 6 weeks from baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in self-reported severity of anorexia
Secondary outcome measures
Anthropometric measures: body mass index (kg/m^2)
Anthropometric measures: weight (kg)
Food intake
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (olanzapine, optional biospecimen collection)Experimental Treatment4 Interventions
Patients receive olanzapine PO for six weeks on study. Patients may also undergo an optional CT scan and blood sample collection on the study.
Group II: Arm II (placebo, olanzapine, optional biospecimen collection)Placebo Group5 Interventions
Patients receive placebo PO for six weeks and then receive olanzapine PO for 6 weeks. Patients also undergo an optional CT scan and collection of blood samples on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Olanzapine
2005
Completed Phase 4
~5480
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,597 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,682 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,845,985 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 (placebo, olanzapine, optional biospecimen collection)
- Group 2: 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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