← Back to Search

Tofacitinib for Diaphragm Injury

Phase 2
Recruiting
Led By Joseph Shrager, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing esophagectomy
Be older than 18 years old
Must not have
Patients taking any immunosuppressant medication (including prednisone) or antifungal medications
Patients with any neuromuscular disease that might compromise diaphragm function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-6 years

Summary

This trial intends to show that a drug which has been shown to prevent VIDD in animals will also work in humans. If successful, this could lead to large clinical trials of the drug.

Who is the study for?
This trial is for patients who are undergoing esophagectomy surgery and do not have neuromuscular diseases, liver or kidney issues, or severe lung problems. They shouldn't be on immunosuppressants or antifungal meds, haven't lost more than 5% of their weight recently, aren't pregnant, and don't have a history of tuberculosis.
What is being tested?
The study tests if Tofacitinib (Xeljanz) can prevent diaphragm muscle weakness caused by mechanical ventilation during surgery compared to a placebo. It's based on previous animal studies showing that blocking certain molecular pathways can prevent this condition.
What are the potential side effects?
Tofacitinib may cause side effects like increased risk of infections due to its immune system suppression effect, potential liver enzyme elevations indicating liver injury, and possibly other common drug-related adverse events such as headaches or digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for or have had an esophagectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking immunosuppressant or antifungal medications.
Select...
I have a condition that could affect my diaphragm's ability to work.
Select...
My liver or kidney function is not normal.
Select...
I have had tuberculosis in the past.
Select...
I have lost more than 5% of my weight in the last 6 months.
Select...
My lung function is better than just mild impairment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition
Secondary study objectives
Increase in muscle strength due to JAK inhibition
Other study objectives
Exploratory: Determine mechanisms of changes in muscle strength and ventilator-induced diaphragm dysfunction by JAK inhibition.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TofacitinibExperimental Treatment1 Intervention
Patient will receive two days treatment with tofacitinib prior to the surgery.
Group II: PlaceboPlacebo Group1 Intervention
Patient will receive two days treatment with placebo prior to the surgery.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,182 Total Patients Enrolled
1 Trials studying Diaphragm Injury
25 Patients Enrolled for Diaphragm Injury
Stanford UniversityLead Sponsor
2,471 Previous Clinical Trials
17,501,942 Total Patients Enrolled
Joseph Shrager, MDPrincipal InvestigatorStanford University

Media Library

Placebo to match Tofacitinib Clinical Trial Eligibility Overview. Trial Name: NCT03681275 — Phase 2
Diaphragm Injury Research Study Groups: Placebo, Tofacitinib
Diaphragm Injury Clinical Trial 2023: Placebo to match Tofacitinib Highlights & Side Effects. Trial Name: NCT03681275 — Phase 2
Placebo to match Tofacitinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03681275 — Phase 2
~0 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top