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Amiodarone for Atrial Fibrillation Prevention in Esophageal Cancer Surgery

Phase 2

Waitlist Available

Led By Stephanie Wood

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

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

Must have

Age > 18 years

Indication of cancer, esophageal dysplasia or esophageal dysmotilities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of discharge (dc) from hospital to 30 days after discharge

Awards & highlights

Study Summary

This trial studies if amiodarone can reduce risk of irregular heart rhythm after esophageal cancer surgery.

Who is the study for?

This trial is for adults over 18 with esophageal cancer or related conditions who are undergoing minimally invasive esophagectomy (MIE). They must understand and consent to the study. Excluded are pregnant or breastfeeding individuals, those with certain heart rate irregularities, current amiodarone users, patients developing AF during surgery, and anyone with a history of adverse reactions to amiodarone.Check my eligibility

What is being tested?

The trial is testing if amiodarone can prevent atrial fibrillation—a common irregular heartbeat—after MIE in esophageal cancer patients. Participants will be randomly assigned to receive either amiodarone or saline as a control after their surgery to see which works better at preventing AF.See study design

What are the potential side effects?

Amiodarone may cause side effects such as lung issues like fibrosis, liver toxicity, thyroid problems, and changes in heart rhythm. The severity of these side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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I have cancer, esophageal dysplasia, or trouble swallowing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initiation of amiodarone in the intensive care unit (icu) to post-operative day (pod) 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from initiation of amiodarone in the intensive care unit (icu) to post-operative day (pod) 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of amiodarone in the intensive care unit (icu) to post-operative day (pod) 30 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone

Secondary outcome measures

30 Day readmission rate

Anastomotic leak

Hospital LOS

+9 more

Side effects data

From 2008 Phase 4 trial • 130 Patients • NCT00127712

34%

Hypotension

death

100%

80%

60%

40%

20%

Study treatment Arm

Control

Amiodarone

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (amiodarone hydrochloride)Experimental Treatment1 Intervention

Patients receive amiodarone hydrochloride IV for 4 days and then via a feeding tube for 3 days on study.

Group II: Arm II (normal saline)Placebo Group1 Intervention

Patients receive normal saline IV for 4 days on study.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,636 Total Patients Enrolled

Stephanie WoodPrincipal InvestigatorOHSU Knight Cancer Institute

Frequently Asked Questions

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

Has the Federal Drug Administration sanctioned Arm I (amiodarone hydrochloride)?

"As this is a Phase 2 clinical trial, which features some data confirming safety but none that verifies efficacy, Arm I (amiodarone hydrochloride) receives an assessment of 2 on our 1 to 3 scale."

Answered by AI

Are participants currently being enrolled in this clinical trial?

"According to records on clinicaltrials.gov, this trial is not presently recruiting patients - it was initially posted on October 9th 2023 and last edited September 28th 2023. Nevertheless, there are 790 other medical studies actively enrolling participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer

Stephanie Wood 2024. "Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067438.

All > Esophageal Cancer