NCT06225011

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate alterations in tumor immune cell composition and activity under SSRI treatment. OUTLINE: Patients receive fluoxetine orally (PO) once daily (QD) for 10 days prior to surgery.

Conditions

• Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Fluoxetine	Receive PO

Timeline

• Start date: 2025-03-20
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2024-01-25
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study