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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
Must not have
A diagnosis of metastatic colorectal adenocarcinoma
Individuals who have received neoadjuvant chemotherapy prior to the planned colon cancer resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within a year of surgery
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with advanced colorectal cancer.
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I have had chemotherapy before my planned colon cancer surgery.
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I cannot take fluoxetine due to health reasons.
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I am currently taking tamoxifen, pimozide, or thioridazine.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Immune cell composition and microenvironment
Side effects data
From 2012 Phase 4 trial • 43 Patients • NCT002456358%
Weight Loss
8%
Stomach Pains
4%
Trouble Sleeping
4%
Nausea
4%
Menstrual Cramps
4%
Insomnia
4%
Nightmares
4%
Silliness/Feeling too happy
4%
Emotional
4%
Suicidal Behavior
4%
Lit Paper on Fire
4%
Fatigue
4%
Decreased Appetite
4%
Sweating
4%
Agitated/Restlessness
4%
Dry Mouth
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Fluoxetine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,184 Total Patients Enrolled
Randolph Hecht, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center