Olanzapine for Stomach Cancer

AE
HD
Overseen ByHilda Diaz, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Illinois at Chicago
Must be taking: Olanzapine
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether low-dose olanzapine can help patients with stomach cancer maintain weight, improve appetite, and enhance nutritional health during chemotherapy. Patients will receive either standard chemotherapy alone or with olanzapine, a medication typically used for mental health, to determine its potential benefits. The trial targets patients with confirmed stomach cancer who are about to begin chemotherapy and surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to benefit from an innovative approach.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you will continue to receive standard chemotherapy treatments, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that olanzapine is likely to be safe for humans?

Research has shown that olanzapine is generally safe for people. Studies have found that it can help increase appetite and improve the quality of life for patients with stomach cancer. Specifically, patients taking olanzapine reported less nausea and vomiting compared to those who did not take it, suggesting that the drug might help manage some chemotherapy side effects.

Evidence also indicates that even a low dose of olanzapine, such as 2.5 mg per day, can prevent chemotherapy-induced nausea and vomiting. Importantly, studies have not identified any major side effects with this dosage. In fact, patients taking olanzapine experienced fewer severe side effects than those not taking the drug, supporting the idea that olanzapine is safe in this context.

Overall, the data suggest that olanzapine is safe and could be helpful for people undergoing chemotherapy for stomach cancer.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about using olanzapine for stomach cancer because it offers a new approach by potentially enhancing the effects of standard chemotherapy. Unlike traditional treatments that focus solely on attacking cancer cells, olanzapine, typically used to treat psychiatric conditions, might help improve the body's response to chemotherapy, potentially leading to better outcomes. By combining olanzapine with standard chemotherapy, there is hope that this could lead to more effective treatment regimens, improving survival rates and quality of life for patients.

What evidence suggests that olanzapine might be an effective treatment for stomach cancer?

Research has shown that olanzapine is primarily used to treat mental health conditions such as schizophrenia and bipolar disorder by balancing brain chemicals like dopamine and serotonin. Although olanzapine is not specifically approved for stomach cancer treatment, researchers are interested in its potential to alleviate symptoms like weight loss and appetite issues in cancer patients. In other contexts, olanzapine has helped individuals gain weight and improve appetite. In this trial, one group of participants will receive neoadjuvant chemotherapy with olanzapine to explore its potential benefits in maintaining weight and nutrition during treatment. However, its use for stomach cancer patients remains under study, and more evidence is needed to confirm its effectiveness.678910

Who Is on the Research Team?

AE

Aslam Ejaz, MD

Principal Investigator

University of Illinois at Chicago (UIC)

Are You a Good Fit for This Trial?

This trial is for adults with stomach cancer who are about to start chemotherapy before surgery. Participants should be able to take oral medication and follow the study plan. People with conditions that could interfere with participation or safety may not be eligible.

Inclusion Criteria

Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines
I am scheduled for chemotherapy before surgery, as planned by my doctor.
I am fully active or able to care for myself.
See 5 more

Exclusion Criteria

I currently have an infection that needs prescription medication.
I get most of my nutrition through a feeding tube.
Pregnant or nursing
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant chemotherapy with or without olanzapine, continuing until surgical resection

16 weeks
Routine clinical monitoring during treatment

Surgical Resection

Participants undergo surgical resection as part of standard care

1 week

Follow-up

A safety follow-up visit occurs approximately 30 days after the final dose of study therapy

4 weeks
1 visit (in-person)

Long-term Follow-up

Participants have long-term follow-up visits every 3 months for 2 years to monitor progression-free survival and overall survival

24 months
Quarterly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Olanzapine

Trial Overview

The study tests if adding a low dose of olanzapine (2.5 mg daily) to standard pre-surgery chemotherapy helps reduce weight loss, improve appetite, and boost nutrition in stomach cancer patients. Patients are randomly assigned to receive either olanzapine plus chemo or just chemo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Neoadjuvant chemotherapy (Standard of Care) + Olanzapine (2.5 mg daily by mouth)Experimental Treatment2 Interventions
Group II: Arm A: Neoadjuvant chemotherapy (Standard of Care)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Citations

Olanzapine: MedlinePlus Drug Information

Olanzapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia.

Olanzapine (Zyprexa): Uses & Side Effects

Olanzapine (Zyprexa) is an antipsychotic that can treat schizophrenia and bipolar disorder. It balances the levels of dopamine and serotonin in your brain.

Olanzapine - StatPearls - NCBI Bookshelf

Olanzapine is a second-generation (atypical) antipsychotic medication. The FDA has approved this medication for schizophrenia if the patient is over the age of ...

Olanzapine

Olanzapine, sold under the brand name Zyprexa among others, is an atypical antipsychotic primarily used to treat schizophrenia and bipolar disorder.

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lybalvi.com

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