Olanzapine for Stomach Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether low-dose olanzapine can help patients with stomach cancer maintain weight, improve appetite, and enhance nutritional health during chemotherapy. Patients will receive either standard chemotherapy alone or with olanzapine, a medication typically used for mental health, to determine its potential benefits. The trial targets patients with confirmed stomach cancer who are about to begin chemotherapy and surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to benefit from an innovative approach.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you will continue to receive standard chemotherapy treatments, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that olanzapine is likely to be safe for humans?
Research has shown that olanzapine is generally safe for people. Studies have found that it can help increase appetite and improve the quality of life for patients with stomach cancer. Specifically, patients taking olanzapine reported less nausea and vomiting compared to those who did not take it, suggesting that the drug might help manage some chemotherapy side effects.
Evidence also indicates that even a low dose of olanzapine, such as 2.5 mg per day, can prevent chemotherapy-induced nausea and vomiting. Importantly, studies have not identified any major side effects with this dosage. In fact, patients taking olanzapine experienced fewer severe side effects than those not taking the drug, supporting the idea that olanzapine is safe in this context.
Overall, the data suggest that olanzapine is safe and could be helpful for people undergoing chemotherapy for stomach cancer.12345Why do researchers think this study treatment might be promising?
Researchers are excited about using olanzapine for stomach cancer because it offers a new approach by potentially enhancing the effects of standard chemotherapy. Unlike traditional treatments that focus solely on attacking cancer cells, olanzapine, typically used to treat psychiatric conditions, might help improve the body's response to chemotherapy, potentially leading to better outcomes. By combining olanzapine with standard chemotherapy, there is hope that this could lead to more effective treatment regimens, improving survival rates and quality of life for patients.
What evidence suggests that olanzapine might be an effective treatment for stomach cancer?
Research has shown that olanzapine is primarily used to treat mental health conditions such as schizophrenia and bipolar disorder by balancing brain chemicals like dopamine and serotonin. Although olanzapine is not specifically approved for stomach cancer treatment, researchers are interested in its potential to alleviate symptoms like weight loss and appetite issues in cancer patients. In other contexts, olanzapine has helped individuals gain weight and improve appetite. In this trial, one group of participants will receive neoadjuvant chemotherapy with olanzapine to explore its potential benefits in maintaining weight and nutrition during treatment. However, its use for stomach cancer patients remains under study, and more evidence is needed to confirm its effectiveness.678910
Who Is on the Research Team?
Aslam Ejaz, MD
Principal Investigator
University of Illinois at Chicago (UIC)
Are You a Good Fit for This Trial?
This trial is for adults with stomach cancer who are about to start chemotherapy before surgery. Participants should be able to take oral medication and follow the study plan. People with conditions that could interfere with participation or safety may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neoadjuvant chemotherapy with or without olanzapine, continuing until surgical resection
Surgical Resection
Participants undergo surgical resection as part of standard care
Follow-up
A safety follow-up visit occurs approximately 30 days after the final dose of study therapy
Long-term Follow-up
Participants have long-term follow-up visits every 3 months for 2 years to monitor progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Olanzapine
Trial Overview
The study tests if adding a low dose of olanzapine (2.5 mg daily) to standard pre-surgery chemotherapy helps reduce weight loss, improve appetite, and boost nutrition in stomach cancer patients. Patients are randomly assigned to receive either olanzapine plus chemo or just chemo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
Citations
Olanzapine: MedlinePlus Drug Information
Olanzapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia.
Olanzapine (Zyprexa): Uses & Side Effects
Olanzapine (Zyprexa) is an antipsychotic that can treat schizophrenia and bipolar disorder. It balances the levels of dopamine and serotonin in your brain.
Olanzapine - StatPearls - NCBI Bookshelf
Olanzapine is a second-generation (atypical) antipsychotic medication. The FDA has approved this medication for schizophrenia if the patient is over the age of ...
Olanzapine
Olanzapine, sold under the brand name Zyprexa among others, is an atypical antipsychotic primarily used to treat schizophrenia and bipolar disorder.
Home page for LYBALVI® (olanzapine and samidorphan ...
LYBALVI is used in adults to treat manic or mixed episodes that happen with bipolar 1 disorder, either alone for short-term (acute) or maintenance treatment.
GI-05: The Impact of Olanzapine Among Patients ...
The study is designed to prospectively assess whether olanzapine improves appetite, mitigates weight loss, and enhances nutritional status and ...
Efficacy of olanzapine in symptom relief and quality of life in ...
Olanzapine can be considered as an effective drug to increase appetite and decrease anxiety and depression in patients with gastric cancer.
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ctv.veeva.com
ctv.veeva.com/study/gi-05-the-impact-of-olanzapine-among-patients-receiving-neoadjuvant-chemotherapy-for-gastric-cancerGI-05: The Impact of Olanzapine Among Patients Receiving ...
The study is designed to prospectively assess whether olanzapine improves appetite, mitigates weight loss, and enhances nutritional status and ...
Randomized Double-Blind Placebo-Controlled Study of ...
This trial assessed the efficacy of olanzapine in stimulating appetite and improving weight gain in patients receiving chemotherapy.
Antipsychotic use is inversely associated with gastric cancer risk
Antipsychotic use was inversely associated with gastric cancer risk, and dose‐dependent effects against gastric cancer were also seen with several individual ...
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