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Fluoxetine Before Colorectal Cancer Surgery

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

  • RegistryNCT06225011
  • PhasePhase 1
  • StatusRecruiting
  • ConditionColorectal Adenocarcinoma Planning Surgery
  • SponsorJonsson Comprehensive Cancer Center
How Fluoxetine works1 min

The drug

What is being tested.

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.

The study

How the trial runs.

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.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • Male or female ≥ 18 years of age at visit 1
  • Previously untreated cytologically or histologically confirmed colorectal adenocarcinoma that will not need neoadjuvant therapy
  • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
  • World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1.5x10^9/L
  • Platelets ≥ 100x10^9/L

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

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How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

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