GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Neoadjuvant chemotherapy
  • Olanzapine

Treatment groups

26 Participants
are divided into 2 treatment groups

Locations

1
University of Illinois Cancer Center60612, ChicagoIllinois, United States

Sponsors and collaborators

University of Illinois at Chicago

Lead sponsor