Amiodarone for Atrial Fibrillation Prevention in Esophageal Cancer Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Stephanie Wood

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Amiodarone

Disqualifiers: Chronic AF, Pregnancy, Breastfeeding, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well amiodarone works in the prevention of atrial fibrillation (AF) after a minimally invasive esophagectomy (MIE) in patients with esophageal cancer. Atrial fibrillation (AF) is an irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the atria. AF is the most common complication after MIE for esophageal cancer. There has never been a study of AF after MIE that has used unbiased assignment of patients to receive preventative amiodarone or not. Further, there is no standard recommendation or guideline for preventative medications, such as amiodarone, to decrease the risk of AF in patients having MIE performed for cancer. In fact, most medical centers in the United States and around the world do not give preventative amiodarone after esophagectomy. Giving amiodarone after MIE surgery may be able to reduce the risk of AF for patients with esophageal cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking amiodarone before surgery.

What data supports the effectiveness of the drug Amiodarone for preventing atrial fibrillation after esophageal cancer surgery?

Research shows that Amiodarone is effective in preventing atrial fibrillation (a type of irregular heartbeat) after esophagectomy (surgery to remove part of the esophagus), which is a common complication that can lead to longer hospital stays and increased risk of death.

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Is amiodarone safe for humans?

Amiodarone has been studied for safety in preventing atrial fibrillation (a type of irregular heartbeat) after esophageal cancer surgery, and these studies generally focus on its use in this context. While the studies aim to assess both effectiveness and safety, they do not provide detailed safety data applicable to all conditions.

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How does the drug amiodarone differ from other treatments for preventing atrial fibrillation after esophageal cancer surgery?

Amiodarone is unique because it is used specifically to prevent atrial fibrillation (irregular heartbeat) after esophageal cancer surgery, a condition for which there are few standard treatments. It can be administered intravenously or through a nasogastric tube, which is a flexible tube inserted through the nose into the stomach, making it versatile for patients who have undergone surgery.

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Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

I have cancer, esophageal dysplasia, or trouble swallowing.

All patients undergoing MIE will be evaluated for potential enrollment

Exclusion Criteria

My minimally invasive esophagectomy was stopped.

Women who could become pregnant must have a negative pregnancy test on the day of surgery.

I have a history of irregular heartbeats.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive amiodarone hydrochloride IV for 4 days and then via a feeding tube for 3 days, or placebo IV for 4 days

7 days

Inpatient stay during treatment

Follow-up

Participants are monitored for safety and effectiveness, including the development of atrial fibrillation and other postoperative complications

60 days

Regular follow-up visits post-discharge

Participant Groups

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.

Group I: Arm I (amiodarone hydrochloride) Experimental Treatment 1 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 Group 1 Intervention

Patients receive normal saline IV for 4 days on study.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

OHSU Knight Cancer Institute Portland, OR

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized, controlled study of amiodarone for prevention of atrial fibrillation after transthoracic esophagectomy. [2015] Atrial fibrillation is common after esophagectomy. The objective of this study was to determine the efficacy and safety of amiodarone for prevention of atrial fibrillation after transthoracic esophagectomy.

2. Germany pubmed.ncbi.nlm.nih.gov

Amiodarone is a cost-neutral way of preventing atrial fibrillation after surgery for lung cancer. [2015] Our aim was to estimate the costs and health benefits of routinely administered postoperative amiodarone as a prophylactic agent in reducing the risk of atrial fibrillation in patients undergoing surgery for lung cancer.

3. United States pubmed.ncbi.nlm.nih.gov

Atrial fibrillation after surgery for esophageal carcinoma: clinical and prognostic significance. [2019] To retrospectively evaluate the clinical relevance, perioperative risk factors, outcome of different pharmacological prophylaxis, and short-term prognostic value of atrial fibrillation (AF) after surgery for esophageal carcinoma.

4. United States pubmed.ncbi.nlm.nih.gov

Amiodarone for prevention of atrial fibrillation following esophagectomy. [2020] Atrial fibrillation (AF) is a common complication after esophagectomy and is associated with symptoms, hemodynamic instability, prolonged hospital stay, and an increased incidence of mortality. Our objective was to determine the efficacy and safety of intravenous amiodarone for prophylaxis of postesophagectomy AF.

5. United States pubmed.ncbi.nlm.nih.gov

Prospective evaluation of serum amiodarone concentrations when administered via a nasogastric tube into the stomach conduit after transthoracic esophagectomy. [2013] Atrial fibrillation occurs in up to 46% of patients following esophagectomy; amiodarone may be used for prophylaxis or treatment in these patients. There are few data regarding drug absorption following esophagectomy.

6. Japan pubmed.ncbi.nlm.nih.gov

Atrial fibrillation after esophageal cancer surgery: an analysis of 207 consecutive patients. [2021] The aim of this study was to identify perioperative risk factors that are associated with postoperative atrial fibrillation (AF) and the outcomes of different pharmacological interventions in esophageal cancer patients who underwent transthoracic esophagectomy.

7. United States pubmed.ncbi.nlm.nih.gov

Application of Amiodarone and Cedilan in the Treatment of Patients with Arrhythmia after Esophageal and Lung Cancer. [2023] To explore the effect of amiodarone and cedilan in the treatment of patients with arrhythmia after esophageal and lung cancer.