University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
NCT Number: NCT07581405
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Chicago, Illinois, 60612, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Neoadjuvant chemotherapy will be administered per standard of care
Olanzapine 2.5 mg will be administered by mouth daily
Time frame: From 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
Time frame: From 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
Time frame: From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
To evaluate the effect of olanzapine on nutritional status during neoadjuvant chemotherapy
Time frame: From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
To evaluate the relationship between olanzapine and the the severity of chemotherapy-related adverse events by utilizing CTCAE version 6.
Time frame: From before treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
To assess changes in quality of life (QoL) during neoadjuvant chemotherapy among patients receiving olanzapine by utilizing the EORTC (QLQ-C30) questionnaire. For the first part of the questionnaire, the scale is 1 to 4, with 4 indicating a worse quality of life. For the second part oft he questionnaire, the scale is 1 to 7 with 1 indicating a worse quality of life.
Time frame: From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
To describe the safety and tolerability profile of low-dose olanzapine when used as a supportive care intervention in this patient population
Time frame: From enrollment to 24 months after study enrollment
Exploratory evaluation of progression-free survival (PFS) based on electronic medical record (EMR) review and treating oncologist assessment.
Time frame: From enrollment to 24 months after study enrollment
Exploratory evaluation of overall survival (OS) based on EMR review.
Time frame: From treatment start to 24 months after study enrollment
To assess the effect of olanzapine on surgical resection rates.
Time frame: From treatment start to 24 months after study enrollment
To assess the effect of olanzapine on perioperative complications.
Time frame: From treatment start to 24 months after study enrollment
To assess the effect of olanzapine on long-term survival.
Contact information is provided by the study sponsor or research team.
Aslam Ejaz, MD
CONTACT
Hilda Diaz, MPH
CONTACT
University of Illinois at Chicago
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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