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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07581405
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neoadjuvant chemotherapy — DRUG
    Neoadjuvant chemotherapy will be administered per standard of care
  • Olanzapine — DRUG
    Olanzapine 2.5 mg will be administered by mouth daily

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2030

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Neoadjuvant chemotherapy (Standard of Care)
    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.
  • Experimental: Arm B: Neoadjuvant chemotherapy (Standard of Care) + Olanzapine (2.5 mg daily by mouth)
    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.

Primary Outcome Measure

To evaluate weight change [ Time Frame: From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612
Aslam Ejaz, MD
[email protected]
312-996-6666
Aslam Ejaz, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
University of Illinois Cancer Center· Chicago, IL

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