What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer that involve modulation of neurotransmitters, such as SSRIs, SNRIs, and TCAs, have various side effects. SSRIs like fluoxetine and sertraline can cause nausea, insomnia, sexual dysfunction, and increased bleeding risk. SNRIs such as venlafaxine and duloxetine may lead to hypertension, dry mouth, and dizziness. TCAs, including amitriptyline and nortriptyline, often result in sedation, weight gain, and anticholinergic effects like dry mouth and constipation. All these antidepressants can lower the seizure threshold and should be used cautiously in patients with CNS disease.

What prior FDA approvals exist?

FDA-approved treatments for pancreatic cancer primarily include chemotherapy agents like gemcitabine and targeted therapies such as erlotinib. While antidepressants like duloxetine and escitalopram are not specifically approved for treating pancreatic cancer, they are used to manage cancer-related symptoms such as pain and depression. These drugs modulate neurotransmitters like serotonin and norepinephrine, which can help alleviate neuropathic pain and improve mood in cancer patients. Their role in cancer treatment is supportive, aiming to enhance the quality of life for patients undergoing cancer therapy.

What other types of research exist?

Promising novel alternatives to antidepressants for pancreatic cancer patients include the use of somatostatin analogs like lanreotide, which has shown antiproliferative effects in neuroendocrine tumors, and corticosteroids like dexamethasone for symptom management. Additionally, treatments such as high-dose progestins for cancer anorexia-cachexia syndrome and methylphenidate for improving cognition, mood, and function in advanced cancer patients may also be considered.

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Escitalopram for Pancreatic Cancer

Phase 2

Waitlist Available

Led By Jordan Winter, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Subjects must not currently be on an antidepressant, anti-anxiety, anti-bipolar, or anti-psychotic medicine

ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-2

Must not have

Metastatic pancreatic or other periampullary cancer

Currently on an antidepressant, anti-anxiety, anti-bipolar or anti-psychotic medicine. Patients who have taken MAOIs (Monoamine Oxidase Inhibitors) within the past 6 months are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years from the treatment date

Summary

This trial is testing the use of antidepressants in people with localized pancreatic and periampullary cancer who are receiving treatment before surgery. Antidepressants help improve mood by balancing brain chemicals. The goal is to see if these medications can improve quality of life and potentially survival rates in these cancer patients.

Who is the study for?

This trial is for adults aged 18-80 with localized pancreatic or periampullary cancer, who are not on antidepressants and have an ECOG score of 0-2. They must be mentally competent, able to consent, not planning immediate surgery, and set for neoadjuvant chemotherapy.

What is being tested?

The study tests if Escitalopram, an antidepressant, helps patients with localized pancreatic cancer undergoing pre-surgery chemo better than a placebo. Participants will either receive the actual drug or a placebo without knowing which one.

What are the potential side effects?

Escitalopram may cause side effects like nausea, sleepiness or insomnia, increased sweating, dry mouth, and sexual dysfunction. It can also affect mood and energy levels.

Eligibility Criteria

Inclusion Criteria

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

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I am not currently taking any medication for depression, anxiety, bipolar disorder, or psychosis.

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I can take care of myself and am up and about more than half of the day.

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I am scheduled for at least 12 weeks of initial chemotherapy.

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My cancer is confirmed to be in the pancreas or nearby areas.

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I have never been diagnosed with bipolar disorder.

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I am mentally capable and willing to sign a consent form.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread from the pancreas or nearby areas.

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I am currently taking medication for depression, anxiety, bipolar disorder, or psychosis, and have not taken MAOIs in the last 6 months.

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I had or will have surgery for pancreatic cancer within the specified time frame.

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I have a history of seizures.

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I am younger than 18 or older than 80.

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I have a history of heart rhythm issues related to long QT syndrome.

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My kidney function is low, with a GFR less than 45.

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I have had a heart attack or unstable heart condition recently.

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My liver disease is moderately to severely advanced.

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I cannot take medicine by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years from the treatment date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years from the treatment date

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from the treatment date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the rate of depression

Secondary study objectives

Quality of Life using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) survey

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004

23%

Sleepiness/Sedation

10%

Headache

Tension/Inner Unrest

Reduced Salivation

Concentration Difficulties

Diminished Sexual Drive

Asthenia/Lassitude/Increased Fatigability

Constipation

Polyuria/Polydipsia

Orthostatic Dizziness

Nausea/Vomiting

Erectile Dysfunction

Failing Memory

Diarrhea

Increased Duration of Sleep

Reduced Duration of Sleep

Increased Dream Activity

Accomodation Disturbance

Increased Tendancy to Sweating

Weight Gain

Ejaculatory Dysfunction

Micturtion Disturbances

100%

80%

60%

40%

20%

Study treatment Arm

Escitalopram and Placebo

Escitalopram and Memantine

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving EscitalopramExperimental Treatment1 Intervention

Group II: Participants receiving PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Escitalopram

2005

Completed Phase 4

~2330

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for pancreatic cancer include surgery, chemotherapy, radiation therapy, and targeted therapy. Chemotherapy drugs, such as gemcitabine and FOLFIRINOX, work by interfering with the DNA replication process in rapidly dividing cancer cells, leading to cell death. Targeted therapies, like erlotinib, inhibit specific molecules involved in tumor growth and progression. While antidepressants are not standard treatments for pancreatic cancer, their modulation of neurotransmitters such as serotonin, norepinephrine, and dopamine can help manage symptoms like pain and depression, which are common in cancer patients. This is crucial as it can improve the overall quality of life and potentially enhance the effectiveness of other cancer treatments by addressing the psychological and neuropathic components of the disease.