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Treatment (fluoxetine) for Colorectal Cancer

Phase 1

Waitlist Available

Led By Randolph Hecht, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Previously untreated cytologically or histologically confirmed colorectal adenocarcinoma that will not need neoadjuvant therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within a year of surgery

Awards & highlights

Study Summary

This trial is testing whether fluoxetine (prozac) can change the immune cells in tumors before surgery in patients with colorectal cancer. Fluoxetine is a medication commonly used to treat depression and anxiety.

Who is the study for?

This trial is for individuals with colorectal cancer who are scheduled for surgery. The study is exploring if fluoxetine, a medication typically used for depression and anxiety, can alter immune cells in the tumor before surgery.Check my eligibility

What is being tested?

The trial is testing fluoxetine's effect on modifying tumor immune cells in colorectal cancer patients. It aims to see if this common antidepressant can change the immune environment of the tumor and potentially hinder cancer growth and spread.See study design

What are the potential side effects?

Fluoxetine may cause side effects like nausea, headaches, sleep disturbances, sexual dysfunction, nervousness or restlessness. More rarely it could affect mood or lead to serious allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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I have a confirmed colorectal cancer diagnosis and don't need pre-surgery treatment.

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My kidneys are working well enough (Ccr ≥ 40 mL/min).

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My heart's electrical activity, measured by QTc, is within normal range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within a year of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within a year of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within a year of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Immune cell composition and microenvironment

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635

Stomach Pains

Weight Loss

Nausea

Trouble Sleeping

Insomnia

Nightmares

Menstrual Cramps

Silliness/Feeling too happy

Emotional

Suicidal Behavior

Lit Paper on Fire

Fatigue

Decreased Appetite

Sweating

Agitated/Restlessness

Dry Mouth

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Fluoxetine

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (fluoxetine)Experimental Treatment1 Intervention

Patients receive fluoxetine PO once QD for 10 days prior to surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluoxetine

2005

Completed Phase 4

~2370

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

361 Previous Clinical Trials

27,802 Total Patients Enrolled

Randolph Hecht, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to apply for this ongoing medical study?

"According to the current information available on clinicaltrials.gov, this trial is not currently accepting new participants. The initial posting of the trial was on June 1st, 2024, and it was last updated on January 17th, 2024. It's worth noting that despite this particular study not actively recruiting at present, there are still a significant number of other trials - specifically, 934 studies - that are presently open for patient enrollment"

Answered by AI

Has the fluoxetine treatment received official approval from the FDA?

"Based on the phase of this trial (Phase 1), our team at Power assigns a safety rating of 1 to Treatment (fluoxetine). This suggests that there is limited data available supporting both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06225011.

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