Gastric Adenocarcinoma, Gastric Cancer
Conditions
Brief summary
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.
Interventions
DRUGNeoadjuvant chemotherapy
Neoadjuvant chemotherapy will be administered per standard of care
DRUGOlanzapine
Olanzapine 2.5 mg will be administered by mouth daily
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate weight change | 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 |
| To evaluate appetite | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate nutritional status using clinical documentation and standard of care lab tests | 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 |
| Type, severity, and number of chemotherapy-related adverse events while using olanzapine as defined by CTCAE version 6 | 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. |
| To evaluate quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | 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. |
| To evaluate safety and tolerability of olanzapine as measured by the type, number, and severity of adverse events assessed by CTCAE version 6 | 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 |
Countries
United States
Contacts
CONTACTAslam Ejaz, MD
CONTACTHilda Diaz, MPH
PRINCIPAL_INVESTIGATORAslam Ejaz, MD
University of Illinois at Chicago (UIC)
Outcome results
None listed