Amiodarone for Atrial Fibrillation Prevention in Esophageal Cancer Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Amiodarone

Disqualifiers: Chronic AF, Pregnancy, Breastfeeding, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if amiodarone, a medication for treating and preventing certain irregular heartbeats, can prevent atrial fibrillation (AF) after esophageal cancer surgery. Patients will receive either amiodarone or a placebo (a substance with no active drug) to compare outcomes. Individuals with esophageal cancer scheduled for a minimally invasive esophagectomy, who do not already have AF or regularly use amiodarone, may be suitable for this study. The goal is to find a reliable method to reduce AF risk in these patients. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant findings.

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.

Is there any evidence suggesting that amiodarone is likely to be safe for humans?

Research has shown that amiodarone, the treatment under study, reduces the risk of atrial fibrillation (AF) in patients after esophagectomy surgery. In one study involving 80 patients who underwent this surgery, amiodarone significantly lowered the number of cases requiring AF treatment. This finding suggests the treatment effectively prevents AF.

Regarding safety, amiodarone is generally well-tolerated, though it can have side effects like any medication. It has been used for a long time and is already approved for other heart rhythm issues. This approval provides some confidence in its safety, but individual experiences may vary. Participants should discuss potential risks and benefits with their healthcare provider to make an informed decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for atrial fibrillation?

Unlike the standard treatments for atrial fibrillation after esophageal cancer surgery, which often rely on beta-blockers or calcium channel blockers, amiodarone offers a unique approach. Amiodarone works by stabilizing the heart's electrical activity, potentially reducing the risk of irregular heartbeats more effectively. Researchers are excited because amiodarone is administered both intravenously and via a feeding tube, making it versatile for patients who might have difficulty with oral medications post-surgery. This dual delivery method could provide more consistent levels of the medication, offering better prevention of atrial fibrillation during the critical recovery period.

What evidence suggests that amiodarone might be an effective treatment for atrial fibrillation after esophageal cancer surgery?

In this trial, participants will join different treatment arms to evaluate the effectiveness of amiodarone in preventing atrial fibrillation (AF) after esophageal cancer surgery. Research has shown that amiodarone can help prevent AF, an irregular heartbeat, following such surgery. In one study with 80 patients who underwent a specific type of esophageal surgery, amiodarone significantly reduced the need for AF treatment. Another study found that taking amiodarone before and after surgery lowered the risk of developing AF. These findings suggest that amiodarone can reduce the chance of AF after esophageal cancer surgery. Participants in this trial may receive either amiodarone or a placebo (normal saline) to assess its effectiveness. ^{1 2 4 5 6}

Who Is on the Research Team?

Stephanie Wood

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Amiodarone

Trial Overview

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Published Research Related to This Trial

In a study of 80 patients undergoing transthoracic esophagectomy, amiodarone significantly reduced the incidence of atrial fibrillation requiring treatment from 40% in the control group to 15%, indicating a 62.5% relative risk reduction.

The use of amiodarone did not lead to significant differences in hospital or intensive care unit stays, nor did it increase the incidence of adverse effects, suggesting it is a safe and effective prophylactic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled study of amiodarone for prevention of atrial fibrillation after transthoracic esophagectomy. Tisdale, JE., Wroblewski, HA., Wall, DS., et al.[2015]

In a study of 27 patients, those who underwent esophagectomy had significantly lower serum amiodarone concentrations after nasogastric administration compared to patients who had pulmonary resection, indicating poor absorption of the drug in the esophagectomy group.

On postoperative days 2 and 4, a notable percentage of patients in the esophagectomy group had undetectable levels of amiodarone, suggesting that nasogastric administration may not be effective for preventing or treating atrial fibrillation after esophagectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of serum amiodarone concentrations when administered via a nasogastric tube into the stomach conduit after transthoracic esophagectomy. Tisdale, JE., Wroblewski, HA., Hammoud, ZT., et al.[2013]

In a study of 254 lung cancer surgery patients, postoperative amiodarone significantly reduced the incidence of atrial fibrillation, with only 11 cases in the amiodarone group compared to 38 in the placebo group (P < 0.001).

The use of amiodarone was cost-neutral, as the mean total costs per patient were similar between the amiodarone and placebo groups (€7288), and there were no adverse effects associated with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amiodarone is a cost-neutral way of preventing atrial fibrillation after surgery for lung cancer. Riber, LP., Christensen, TD., Pilegaard, HK.[2015]

In a study of 60 patients with arrhythmias after esophageal and lung cancer surgery, amiodarone was found to be significantly more effective than cedilan, with a higher treatment success rate and faster onset of action.

Patients treated with amiodarone also experienced better cardiac function, lower ventricular rates, and fewer adverse reactions compared to those treated with cedilan, indicating it may be a safer and more effective option for managing postoperative arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Amiodarone and Cedilan in the Treatment of Patients with Arrhythmia after Esophageal and Lung Cancer. Ge, H.[2023]

Atrial fibrillation (AF) is more common after esophageal surgery in older male patients, particularly those with a history of chronic obstructive pulmonary disease (COPD) or cardiac disease, and is associated with postoperative hypoxia and thoracic-gastric dilatation.

Despite the increased incidence of AF in these patients, there was no significant difference in short-term mortality or length of hospital stay between those with AF and those without.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial fibrillation after surgery for esophageal carcinoma: clinical and prognostic significance. Ma, JY., Wang, Y., Zhao, YF., et al.[2019]

In a study of 220 matched patients who underwent esophagectomy, prophylactic intravenous amiodarone significantly reduced the incidence of atrial fibrillation (AF) requiring treatment, with 15.5% in the amiodarone group compared to 29.1% in the control group.

While amiodarone effectively lowered AF rates, it was associated with higher risks of hypotension, bradycardia, and prolonged QT intervals, indicating potential safety concerns despite its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amiodarone for prevention of atrial fibrillation following esophagectomy. Tisdale, JE., Jaynes, HA., Watson, MR., et al.[2020]

In a study of 207 esophageal cancer patients who underwent transthoracic esophagectomy, postoperative atrial fibrillation (AF) occurred in 9.2% of patients, with effective antiarrhythmic treatment in 63.2% of cases.

Postoperative AF was significantly linked to the use of an ileo-colon for reconstruction and the presence of tachycardia (heart rate >100 bpm) on the first postoperative day, highlighting the importance of identifying high-risk patients for targeted prophylactic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial fibrillation after esophageal cancer surgery: an analysis of 207 consecutive patients. Ojima, T., Iwahashi, M., Nakamori, M., et al.[2021]

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In a study by Vaporciyan et al. (12) the risk of AF was 34% in elderly patients receiving chemo(radio)therapy followed by surgery versus 18% in the group that ...