Steroid for Swallowing Difficulty

Overseen By Jenn Eicher, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: West Virginia University

Must not be taking: Chronic steroids

Disqualifiers: Trauma, Tumor, Neoplastic, Infectious, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

78 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on chronic steroids, you cannot participate.

Is dexamethasone generally safe for humans?

Dexamethasone has been studied in various conditions and is generally considered safe for humans, though it can cause side effects like vomiting, especially in children. It may also affect hormone levels, as seen in studies with asthma patients, but these effects are usually mild. ^{1 2 3 4 5}

How is the drug dexamethasone unique for treating swallowing difficulty?

Dexamethasone is unique because it is a steroid that can be used in a shorter duration compared to other steroids, potentially improving patient compliance and reducing side effects. While it is commonly used for asthma, its application for swallowing difficulty may offer a novel approach, especially if there are no standard treatments for this condition. ^{1 6 7 8 9}

Research Team

Scott Daffner, MD

Principal Investigator

West Virginia University

Eligibility Criteria

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.

Inclusion Criteria

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

I am between 18 and 80 years old.

Exclusion Criteria

No phone

I am on long-term steroid medication.

My condition is due to an injury or tumor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of either intravenous dexamethasone or saline within one hour of the incision during anterior cervical spine surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for swallowing function and clinical outcomes using various questionnaires at multiple time points post-operatively

12 months

Multiple visits (in-person and virtual) at Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• Dexamethasone
• Saline

Trial Overview 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.

Participant Groups

Group I: Treatment 1; Dexamethasone Experimental Treatment 1 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; Placebo Placebo Group 1 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.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Findings from Research

In a study of 1161 children aged 4 to 17 hospitalized for asthma exacerbations, dexamethasone was compared to prednisone, showing a slightly higher return utilization rate of 3.9% versus 2.2%, respectively.

However, the analysis indicated that the choice of steroid (dexamethasone vs. prednisone) did not significantly impact the likelihood of unplanned readmissions or emergency department visits within 30 days after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone Versus Prednisone in Children Hospitalized With Asthma Exacerbation. Hoefgen, ER., Huang, B., Schuler, CL., et al.[2022]

References

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

A Randomized Controlled Study Addressing Dexamethasone Tolerability in the Treatment of Acute Asthma in Children: Mary Poppins on Trial! [2023]

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

Comparative clinical study of inhaled beclomethasone dipropionate and triamcinolone acetonide in persistent asthma. [2013]

3. France pubmed.ncbi.nlm.nih.gov

[Pharmacokinetics of dexamethasone administered orally in obese patients]. [2013]

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

Effect of concomitant administration of magnesium trisilicate on GI absorption of dexamethasone in humans. [2019]

5. England pubmed.ncbi.nlm.nih.gov

First-time treatment with steroids in bronchial asthma: comparison of the effects of inhaled beclomethasone and of oral prednisone on airway function, bronchial reactivity and hypothalamic-pituitary-adrenal axis. [2013]

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

Treatment of asthma with triamcinolone acetonide aerosol. [2019]

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

Is dexamethasone an effective alternative to oral prednisone in the treatment of pediatric asthma exacerbations? [2014]

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

A one-year trial of triamcinolone acetonide aerosol in severe steroid-dependent asthma. [2019]

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

Dexamethasone Versus Prednisone in Children Hospitalized With Asthma Exacerbation. [2022]