Itraconazole for Barrett's Esophagus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests itraconazole, a medication, to determine if it can prevent the recurrence of Barrett's esophagus (BE) after treatment. BE can lead to esophageal cancer if it returns, which occurs in many patients even after successful initial treatment. The trial compares two forms of itraconazole—a liquid solution and a capsule—to identify which might be more effective. Suitable candidates for this trial have Barrett's esophagus with specific conditions and plan to undergo endoscopic treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it excludes people with critical drug interactions with medications metabolized by cytochrome P450 (CYP)3A4. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that itraconazole is generally safe for humans. The FDA has already approved it to treat fungal infections like esophageal candidiasis, a fungal infection in the esophagus. This approval indicates prior use in people, providing some reassurance about its safety.
Common side effects of itraconazole include nausea, headache, and stomach pain, which are usually mild and resolve on their own. However, itraconazole can rarely cause serious side effects like liver or heart problems. Anyone considering joining the trial should discuss these risks with their doctor.
The trial for Barrett's esophagus uses both liquid and capsule forms of itraconazole. Both forms have similar safety records, but monitoring how the body reacts to any new treatment is important. Participants should maintain communication with the trial team and report any side effects they notice.12345Why are researchers excited about this trial's treatments?
Researchers are excited about itraconazole for Barrett's Esophagus because it offers a novel approach by repurposing an antifungal medication for this condition. Unlike standard treatments that focus on acid suppression, itraconazole may work by impacting molecular pathways involved in esophageal cell changes. The trial explores two forms of delivery—solution and capsule—potentially offering flexibility and improved patient adherence compared to existing therapies. This unique mechanism and delivery method could lead to more effective management of Barrett's Esophagus, sparking interest in its potential benefits.
What evidence suggests that itraconazole might be an effective treatment for Barrett's esophagus?
Research suggests that itraconazole might help prevent the recurrence of Barrett's esophagus (BE). Studies have shown that itraconazole can block certain processes in the body that lead to BE. It has also slowed the growth of esophageal cancer cells in some cases. Additionally, animal studies have demonstrated that itraconazole can reduce the development of esophageal adenocarcinoma, a type of cancer. This trial tests both the solution and capsule forms of itraconazole to determine if they can prevent BE from returning after initial treatment.36789
Are You a Good Fit for This Trial?
This trial is for patients with Barrett's esophagus who may have low to high-grade dysplasia or early-stage cancer and are set for endoscopic treatment. They should be relatively active (ECOG 0-2). It's not for those unable to consent, with severe heart failure, liver issues, allergy to itraconazole, pregnant women, or those on certain other drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive itraconazole in either solution or capsule form to prevent recurrent Barrett's esophagus
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of itraconazole effects on angiogenesis and molecular pathways
What Are the Treatments Tested in This Trial?
Interventions
- Itraconazole
Trial Overview
The study tests Itraconazole in capsule and solution forms as a preventive treatment against the recurrence of Barrett's Esophagus after initial successful therapy. The goal is to improve long-term outcomes by preventing relapse which could lead to cancer.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants in this arm will receive the solution form of itraconazole
Participants in this arm will receive the capsule form of itraconazole
Itraconazole is already approved in United States, European Union, Canada, Japan for the following indications:
- Fungal infections
- Histoplasmosis
- Aspergillosis
- Blastomycosis
- Fungal infections
- Histoplasmosis
- Aspergillosis
- Blastomycosis
- Fungal infections
- Histoplasmosis
- Aspergillosis
- Blastomycosis
- Fungal infections
- Histoplasmosis
- Aspergillosis
- Blastomycosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
University of Texas, Southwestern Medical Center at Dallas
Collaborator
Citations
Itraconazole to Prevent Recurrent Barrett's Esophagus
Itraconazole drug and blood levels, The primary endpoint will be the tissue (in esophageal biopsies) and blood concentrations of itraconazole. 8-12 months after ...
Itraconazole for Barrett's Esophagus · Info for Participants
Trial Overview The study tests Itraconazole in capsule and solution forms as a preventive treatment against the recurrence of Barrett's Esophagus after initial ...
Top Barrett's Esophagus Clinical Trials | Power
This phase II trial tests how well itraconazole works in combination with standard of care endoscopy with ablation for the prevention of esophageal cancer ...
Targeting the Hedgehog Pathway Using Itraconazole to ...
Itraconazole significantly decreases EAC development and SHH expression in a preclinical animal model of BM. In humans, BE tissue expresses ...
Systematic mapping of registered interventional studies ...
What is the long-term effectiveness of endoscopic treatment (radiofrequency ablation) for precancerous Barrett's oesophagus or early cancers?
Itraconazole (oral route) - Side effects & dosage
Itraconazole is used to treat serious fungal or yeast infections. Itraconazole oral solution is only used to treat oropharyngeal or esophageal candidiasis ( ...
SPORANOX (itraconazole) Capsules BOXED WARNING ...
Limited data on the safety of long-term use (>6 months) of. SPORANOX. ®. Oral Solution are available at this time. The recommended dosage of SPORANOX. ®. Oral ...
Itraconazole: Uses, Interactions, Mechanism of Action
Itraconazole is rapidly absorbed after oral administration. As oral capsules, peak plasma concentrations of itraconazole are reached within two to five hours.
Sporanox (Itraconazole Capsules): Side Effects, Uses, ...
Limited data on the safety of long-term use (>6 months) of SPORANOX® Oral Solution are available at this time. The recommended dosage of SPORANOX® Oral ...
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