Olanzapine added to chemotherapy for gastric cancer to help keep weight and appetite up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, open-label Phase 2 trial evaluating low-dose olanzapine (2.5 mg daily) in addition to standard neoadjuvant chemotherapy for gastric adenocarcinoma. Participants begin olanzapine before chemotherapy and continue until surgical resection, with no changes to the chemotherapy or planned surgery. The trial will assess weight, appetite, nutritional status, and quality of life to see if olanzapine can mitigate treatment-related weight loss. The study plans to enroll about 26 adults at the University of Illinois Cancer Center over two years. Outcomes will inform whether this approach improves nutritional and patient-reported endpoints during neoadjuvant therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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) who receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment are excluded because the primary endpoints of appetite and weight change may not accurately reflect oral intake or appetite response in this population.
* Other major comorbidity, as determined by the study PI
* Patients currently taking medications that may interact with olanzapine, including, but not limited to, other anti-psychotics, CNS depressants, or dopamine agonists.
* Patients with a clinically significant cardiac history or clinically significant QTc prolongation that, in the opinion of the treating investigator, would make olanzapine administration unsafe.
* Patients with uncontrolled hyperglycemia that, in the opinion of the treating investigator, would make olanzapine administration unsafe.

Where it's running

• University of Illinois Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Aslam Ejaz, MD — University of Illinois at Chicago (UIC)
• Study coordinator: Aslam Ejaz, MD
• Email: aejaz@uic.edu
• Phone: 312-996-6666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.