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GI-05: Olanzapine for Gastric Cancer During Chemotherapy

This study is looking at how a low dose of olanzapine (a medication often used for mental health conditions) might help patients with gastric (stomach) cancer who are receiving chemotherapy before surgery. The goal is to see if olanzapine can improve appetite, prevent weight loss, and boost overall nutrition and quality of life during this treatment. You would receive olanzapine 2.5 mg by mouth daily in addition to your standard chemotherapy. The study plans to enroll 26 participants and is currently unclear on its recruitment status. Success would mean participants experience less weight loss and improved appetite over approximately 16 weeks.

Study design
This is a single-center, randomized, open-label study involving 26 participants. Participants will be randomly assigned to receive either standard chemotherapy alone or standard chemotherapy plus olanzapine.
What's involved
You would take olanzapine 2.5 mg by mouth daily, starting before chemotherapy and continuing until surgery. Your weight and appetite will be measured from the start of treatment until 30 days after chemotherapy ends (about 16 weeks).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for weight and appetite changes from the start of treatment until 30 days after the end of neoadjuvant chemotherapy, which is approximately 16 weeks from the treatment start.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07581405

GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Illinois at Chicago
~26 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Neoadjuvant chemotherapyOlanzapine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate weight change
Measured over From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
+1 more outcome measured

Conditions

Gastric Adenocarcinoma
Gastric Cancer

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Gastric Adenocarcinoma

NCT07581405

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Illinois Cancer Center

    Chicago, Illinoisstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Aslam Ejaz, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago (UIC)

Who to contact

Aslam Ejaz, MD
[email protected]
312-996-6666
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 18 years of age at time of consent
Eastern Cooperative Oncology Group (ECOG) score of 0-2
Histologically confirmed gastric adenocarcinoma, documented by biopsy.
Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist.
Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.
Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board informed consent form and HIPAA authorization. If a subject is unable to consent, a Legally Authorized Representative (LAR) may provide consent on their behalf.
Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study

Exclusion

Active infection requiring systemic therapy
Uncontrolled HIV/AIDS or active viral hepatitis
Pregnant or nursing
Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
Patients with a feeding tube (e.g., gastrostomy or jejunostomy) receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment.
Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
Other major comorbidity, as determined by the study PI

What this trial measures

  • To evaluate weight changeFrom treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)

    To evaluate the effect of olanzapine on weight change in patients with gastric cancer receiving neoadjuvant chemotherapy

  • To evaluate appetiteFrom treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)

    To evaluate the effect of olanzapine on appetite in patients with gastric cancer receiving neoadjuvant chemotherapy