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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Neoadjuvant chemotherapy will be administered per standard of care
Olanzapine 2.5 mg will be administered by mouth daily
University of Illinois Cancer Center
Chicago, Illinois, United States
To evaluate weight change
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 appetite
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 nutritional status using clinical documentation and standard of care lab tests
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)
Type, severity, and number of chemotherapy-related adverse events while using olanzapine as defined by CTCAE version 6
To evaluate the relationship between olanzapine and the the severity of chemotherapy-related adverse events by utilizing CTCAE version 6.
Time frame: From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
To evaluate quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
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 before treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
To evaluate safety and tolerability of olanzapine as measured by the type, number, and severity of adverse events assessed by CTCAE version 6
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 treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
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