RecruitingPhase 1NCT06225011

Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer

Repurposing Drugs as Immunotherapeutic Agents: Changes in Colorectal Tumor Immune Cells After Targeting Serotonin


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

10 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests whether fluoxetine (prozac) works to modify the tumor immune cells before surgery in patients with colorectal cancer. Fluoxetine is a commonly used selective serotonin reuptake inhibitor (SSRI) prescribed for major depressive disorder and generalized anxiety. Giving fluoxetine may modify the immune cell composition in the tumor and its microenvironment and may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread in patients with colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether fluoxetine (an antidepressant commonly known as Prozac) given before surgery can change the immune environment inside colorectal tumors in a way that might improve surgical outcomes. Researchers will analyze the tumor tissue after surgery to see if the drug had any effect on immune cells within the cancer. **You may be eligible if...** - You are 18 years old or older - You have been newly diagnosed with colorectal cancer (confirmed by biopsy) that will be treated with surgery and does not require pre-surgical chemotherapy - Your cancer has not spread to other organs - Your overall health status is acceptable (ECOG 0–2) - Your blood counts, liver, and kidney function are within acceptable range - Your heart rhythm (QTc interval) is normal **You may NOT be eligible if...** - You are currently taking antidepressants (SSRIs, SNRIs, MAOIs, or tricyclics) or lithium - You have a contraindication to fluoxetine (including a prolonged QTc on ECG) - You are currently taking tamoxifen, pimozide, or thioridazine - Your cancer has already spread (metastatic) - You have had another cancer within the past 5 years (skin cancer, excluding melanoma, is okay) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluoxetine

Receive PO


Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

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NCT06225011


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