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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Neoadjuvant chemotherapy
DrugNeoadjuvant chemotherapy will be administered per standard of care
Olanzapine
DrugOlanzapine 2.5 mg will be administered by mouth daily
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Arm A: Neoadjuvant chemotherapy (Standard of Care)Active comparator 1 intervention
Group B: Arm B: Neoadjuvant chemotherapy (Standard of Care) + Olanzapine (2.5 mg daily by mouth)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
To evaluate progression-free survival (PFS)
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 enrollment2
To evaluate overall survival (OS)
Exploratory evaluation of overall survival (OS) based on EMR review.
Time frame
From enrollment to 24 months after study enrollment3
To evaluate surgical resection rates
To assess the effect of olanzapine on surgical resection rates.
Time frame
From treatment start to 24 months after study enrollment4
To evaluate perioperative complications
To assess the effect of olanzapine on perioperative complications.
Time frame
From treatment start to 24 months after study enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: