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Olanzapine for Appetite Loss in 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 4, 8, and 12 weeks from baseline

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.

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.

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 4, 8, and 12 weeks from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4, 8, and 12 weeks from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4, 8, and 12 weeks from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients exhibiting weight gain greater 5%

Secondary study objectives

Anorexia

Appetite

Change in Weight

+12 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm IIExperimental Treatment2 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 Treatment2 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 Group2 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

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