What is the mechanism of action of this treatment?

The most common treatments for swallowing difficulty, particularly the use of perioperative IV steroids, work primarily through their anti-inflammatory effects. Steroids like dexamethasone reduce swelling and inflammation in the tissues surrounding the esophagus, which can alleviate pressure and improve esophageal function. This is crucial for patients with swallowing difficulties as it can significantly enhance their ability to swallow, reduce discomfort, and improve overall quality of life. Other treatments may include behavioral therapies, dietary modifications, and surgical interventions, all aimed at addressing the underlying causes of dysphagia.

What side effects are associated with this type of intervention?

Common treatments for swallowing difficulty, such as perioperative IV steroids, are used to reduce swelling and inflammation. Known side effects of these steroids can include increased blood sugar levels, fluid retention, hypertension, and potential for infection. Other treatments for dysphagia, like local corticosteroid application, may reduce the incidence and severity of postoperative dysphagia but can also lead to rare complications such as bone nonunion and esophageal perforation. General treatments for dysphagia might include dietary modifications, swallowing therapy, and in some cases, surgical interventions, each with their own specific side effects ranging from minor discomfort to more significant surgical risks.

What prior FDA approvals exist?

FDA-approved treatments for swallowing difficulties often involve the use of corticosteroids to reduce inflammation and swelling. For instance, local intraoperative corticosteroid application has been shown to decrease the incidence and severity of postoperative dysphagia following anterior cervical spine surgery. These treatments leverage the anti-inflammatory properties of steroids to improve swallowing function by minimizing tissue swelling and inflammation that can obstruct the esophagus or pharynx.

What other types of research exist?

Promising alternatives to perioperative IV steroids for treating swallowing difficulties include intralesional corticosteroid injections for esophageal strictures and local corticosteroid application during surgery. Injectable soft tissue fillers, such as hyaluronic acid, may also be considered for improving related conditions like glottal insufficiency.

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Corticosteroid

Steroid for Swallowing Difficulty

Phase 4

Waitlist Available

Led By Scott Daffner, MD

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

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

Must have

Elective anterior approach to subaxial cervical spine (C3 - T1)

Ages 18-80

Must not have

Patients on chronic steroids

Traumatic or tumor etiologies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether a single dose of steroids given through an IV can help with swallowing problems after neck surgery. The study focuses on patients who have anterior cervical spine surgery. Steroids might help by reducing inflammation and swelling, making it easier for these patients to swallow after their operation.

Who is the study for?

This trial is for adults aged 18-80 who are having elective neck spine surgery from the front (C3 - T1 level). It's not for those with past neck surgeries, on long-term steroids, pregnant, without a phone, or needing to wear a halo vest after surgery. People with trauma or tumors aren't eligible either.

What is being tested?

The study is testing if giving a single dose of Dexamethasone (a steroid) instead of saline (saltwater) during surgery can help with swallowing difficulties that sometimes follow anterior cervical spine operations. Participants won't know which treatment they receive.

What are the potential side effects?

Dexamethasone may cause side effects like increased blood sugar levels, mood changes, stomach ulcers, and trouble fighting infections. Saline typically has no side effects but might cause vein irritation.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for a specific neck surgery from the front, targeting vertebrae C3 to T1.

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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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I am on long-term steroid medication.

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My condition is due to an injury or tumor.

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I am under 18 years old.

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I have had surgery on the front part of my neck spine before.

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I need surgery for a tumor or infection.

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I am on a breathing machine after surgery.

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I am having surgery that involves both the front and back of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year 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 occurrence of dysphagia and its associated complications

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Cerebrospinal fluid leak

Deep Vein Thrombosis

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment 1; DexamethasoneExperimental Treatment1 Intervention

Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.

Group II: Treatment 0; PlaceboPlacebo Group1 Intervention

Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

0 / 9Eligibility 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 swallowing difficulty, particularly the use of perioperative IV steroids, work primarily through their anti-inflammatory effects. Steroids like dexamethasone reduce swelling and inflammation in the tissues surrounding the esophagus, which can alleviate pressure and improve esophageal function. This is crucial for patients with swallowing difficulties as it can significantly enhance their ability to swallow, reduce discomfort, and improve overall quality of life. Other treatments may include behavioral therapies, dietary modifications, and surgical interventions, all aimed at addressing the underlying causes of dysphagia.

The effect of local intraoperative corticosteroid application on postoperative dysphagia following anterior cervical spine surgery.The Effect of Local Intraoperative Steroid Administration on the Rate of Postoperative Dysphagia Following ACDF: A Study of 245,754 Patients.Oesophageal lichen planus: the efficacy of topical steroid-based therapies.