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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a single dose of the steroid dexamethasone affects swallowing after neck surgery. Researchers aim to determine if it can improve swallowing in patients undergoing elective anterior cervical spine surgery, a specific type of neck surgery. Participants will receive either the steroid or a saline solution (acting as a placebo) during their surgery. This trial suits individuals planning this type of neck surgery who have not previously undergone similar surgeries or have certain other medical conditions. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how dexamethasone can benefit more patients.

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.

What is the safety track record for these treatments?

Research has shown that dexamethasone, the treatment under study, has been used safely in many situations. One study found that taking dexamethasone three times during surgery reduced swallowing problems without major safety issues. Other studies have indicated that short courses of oral dexamethasone are generally safe, provided there are no contraindications due to other health issues.

Common side effects include stomach irritation, anxiety, and trouble sleeping. Taking dexamethasone with food can help prevent stomach problems. Dexamethasone is already approved for treating other conditions, suggesting it is well-tolerated by many people.

Overall, while some side effects are possible, dexamethasone has a history of safety when used for short periods, especially under the care of healthcare professionals. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for swallowing difficulties, which often involve dietary changes, swallowing therapy, or surgical interventions, dexamethasone offers a pharmacological approach that could reduce inflammation quickly and effectively. Dexamethasone is a powerful steroid that could minimize swelling and improve swallowing by targeting inflammation directly at the surgical site. Researchers are excited because this treatment has the potential to provide rapid relief from swallowing difficulties, potentially enhancing recovery times and improving patient outcomes following anterior cervical spine surgery.

What is the effectiveness track record for Dexamethasone in treating swallowing difficulty after anterior cervical spine surgery?

Research has shown that dexamethasone, which participants in this trial may receive, can help with swallowing difficulties after surgery. One study found that patients who received dexamethasone before surgery experienced fewer swallowing problems than those given a placebo. In this trial, participants will be randomized to receive either a single dose of dexamethasone or a saline placebo. Another study found that steroids like dexamethasone can reduce swallowing issues for up to a month after surgery. These studies suggest that dexamethasone effectively improves swallowing problems related to surgeries, such as anterior cervical spine surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Scott Daffner, MD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

No phone

I am on long-term steroid medication.

My condition is due to an injury or tumor.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7508280/

The Effects of Perioperative Corticosteroids on Dysphagia ... We found that a 3-dose regimen of perioperative IV dexamethasone was associated with significantly less dysphagia as measured with use of 2 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9152901/

A Double-Blinded, Prospective, Randomized Controlled Trial Our results demonstrated that preoperative intravenous dexamethasone 10 mg was better than the placebo for improving dysphagia and odynophagia in the first 72 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0972978X24003222

Investigating the use of peri-operative systemic steroid ... Results. Six studies were included and showed that IV steroids effectively mitigated dysphagia for up to a month, with higher efficacy compared to topical ...

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/485960

Effectiveness of Oral Dexamethasone in the Treatment ... Our data demonstrate that immunocompetent children with moderate to severe pharyngitis benefited from the use of oral dexamethasone in achieving earlier onset ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03311425

Effect of Local Intraoperative Steroid on Dysphagia After ... Postoperative dysphagia has been reported to improve with time with a mean incidence of 19.8% at 6 months, 16.8% at 12 months, and 12.9% at 24 months after ACDF ...

6. webmd.com webmd.com/drugs/2/drug-6751/dexamethasone-sodium-phosphate-injection/details

Dexamethasone (Decadron) - Uses, Side Effects, and More Trouble swallowing or throat tightness; Itching, skin rash, or pale red bumps on the skin called hives; Nausea or vomiting; Dizziness, feeling ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/dexamethasone-oral-route/description/drg-20075207

Dexamethasone (oral route) - Side effects & dosage Safety and efficacy have not been established. Appropriate studies performed to date have not demonstrated pediatric-specific problems that ...

8. goodrx.com goodrx.com/dexamethasone/what-is?srsltid=AfmBOor6Brdq5SZ30wO-CVTbLR2viBPqpILi5jeqm4IGo0BRXycOuBYR

Dexamethasone (Decadron): Uses, Side Effects ... Dexamethasone can irritate your stomach so it is best to take it with food. · Dexamethasone can cause you to feel anxious or have a harder time falling asleep.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5470351/

Effect of Oral Dexamethasone Without Immediate Antibiotics ... Short courses of oral steroids have been shown to be safe, in the absence of contraindications. A systematic review reported that participants with a sore ...