Olanzapine for Stomach Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a single-center, randomized, open-label clinical trial designed to evaluate the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy. Eligible patients will be randomized to receive olanzapine 2.5 mg orally once daily (QD) in addition to standard neoadjuvant chemotherapy, beginning prior to initiation of chemotherapy and continuing until surgical resection. Patients will otherwise receive standard-of-care (SOC) oncologic treatment, with no alterations to chemotherapy regimens or surgical management. The study is designed to prospectively assess whether olanzapine improves appetite, mitigates weight loss, and enhances nutritional status and quality of life (QoL) during neoadjuvant therapy. This study will be conducted at the University of Illinois Cancer Center (UICC) as a single-site investigator-initiated trial, with an anticipated accrual of 26 participants over 2 years.
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neoadjuvant chemotherapy with or without olanzapine, continuing until surgical resection
Surgical Resection
Participants undergo surgical resection as part of standard care
Follow-up
A safety follow-up visit occurs approximately 30 days after the final dose of study therapy
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
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
Participants will receive neoadjuvant chemotherapy treatment per standard of care in addition to concurrent dosage of olanzapine 2.5 mg orally once a day. They will receive routine clinical monitoring during treatment followed by a surgical resection per standard of care. A safety follow-up visit will occur approximately 30 days after the final dose of study therapy followed by long-term follow-up visits every 3 months for 2 years.
Participants will receive neoadjuvant chemotherapy treatment per standard of care. They will receive routine clinical monitoring during treatment followed by a surgical resection per standard of care. A safety follow-up visit will occur approximately 30 days after the final dose of study therapy followed by long-term follow-up visits every 3 months for 2 years.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
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