Sucralfate for Esophagitis

Not currently recruiting at 6 trial locations

Overseen By Daniel Gomez

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Opioids

Disqualifiers: PEG tube, Opioid use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores methods to prevent and reduce symptoms of radiation esophagitis, a painful inflammation of the esophagus that can occur during chest radiation therapy. The study compares the effectiveness of sucralfate, a medication that coats and protects the esophagus, against usual care, which involves standard supportive care using opioids. Researchers aim to understand the symptoms participants experience and any changes in their weight. Individuals undergoing chest radiation and at high risk for esophageal irritation might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively taking opioid pain medications before starting radiation therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sucralfate is generally safe for people. It is already used to treat and prevent certain types of ulcers, indicating a history of safe use. Sucralfate works by creating a protective layer over the ulcer, acting directly on the area with minimal absorption into the body. This local action contributes to its relative safety.

Constipation is the most common side effect, affecting about 1% to 10% of people. No serious side effects are commonly linked to oral sucralfate. It is important to remember that the liquid form should not be injected, as this can be dangerous. Overall, evidence suggests sucralfate is safe for most people when taken by mouth as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about sucralfate for esophagitis because it offers a unique approach compared to standard treatments, which often involve opioids for pain management. Sucralfate works by forming a protective barrier on the esophageal lining, helping to heal and soothe inflammation directly, rather than just masking the pain. This mechanism not only targets the root of the problem but also potentially reduces the need for opioids, which can have significant side effects. Additionally, sucralfate's availability in both oral suspension and tablet forms provides flexibility in administration, catering to patient preferences and needs.

What evidence suggests that sucralfate might be an effective treatment for esophagitis?

Research has shown that sucralfate, a treatment under study in this trial, may help treat esophagitis, which is inflammation of the esophagus. In earlier studies, about 53% of patients with reflux esophagitis experienced relief after using sucralfate, and 31% achieved complete healing. It also reduced complications in severe cases of corrosive esophagitis. Sucralfate forms a protective layer on the esophagus, shielding it from harm and aiding in healing. Additionally, it is generally safe with few side effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Jacob Shin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing thoracic irradiation and have a high risk of developing esophagitis due to their treatment. It's not for those with feeding tubes, current opioid use, known issues taking Sucralfate, or a history of opioid addiction.

Inclusion Criteria

My esophagus radiation dose is within the specified range.

My esophageal radiation dose is within the specified range.

I am receiving chest radiation that is considered high-risk for my esophagus.

Exclusion Criteria

I cannot take Sucralfate as advised by my doctor.

History of an opioid use disorder

I am currently using opioid painkillers before starting radiation therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive thoracic irradiation and are randomized to receive either sucralfate or usual care

Duration not specified

Weekly status checks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid use and weight loss

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Sucralfate
• Usual Care

Trial Overview

The study tests if Sucralfate can prevent or reduce radiation esophagitis symptoms compared to usual care during thoracic irradiation. Researchers will monitor symptom differences and weight loss among participants.

How Is the Trial Designed?

Group I: Two Stage Consent Experimental Treatment 1 Intervention

Patient will sign two consent forms.

Group II: Sucralfate Experimental Treatment 1 Intervention

During their RT course, patients randomized to the PS arm will receive a prescription for either: 1) sucralfate, 1 gram/10 mL oral suspension or 2) sucralfate 1 gram tablets.

Group III: One Stage Consent Active Control 1 Intervention

Patient will sign one consent form.

Group IV: Usual Care Active Control 1 Intervention

Standard supportive care by using opioids.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 75 patients with reflux esophagitis, both sucralfate alone and a combination of sucralfate and ranitidine showed similar levels of symptomatic improvement after 8 weeks.

Endoscopic results indicated that sucralfate monotherapy is as effective as the combination therapy, with 67% and 74% showing improvement respectively, suggesting that the combination treatment may not be necessary for milder cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy of sucralfate and ranitidine, compared with sucralfate monotherapy, in patients with peptic reflux esophagitis. Vermeijden, JR., Tytgat, GN., Schotborgh, RH., et al.[2022]

In a study of 49 patients with primary reflux esophagitis, both sucralfate and ranitidine were found to be equally effective in healing the condition after eight weeks, with 14 patients healed on sucralfate and 13 on ranitidine.

Both treatments showed similar positive effects on symptoms and were well-tolerated, although one ranitidine patient experienced an allergic rash, suggesting that sucralfate could be a safe alternative for treating reflux esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effect of sucralfate and ranitidine in reflux esophagitis. Simon, B., Mueller, P.[2019]

In a double-blind, placebo-controlled trial involving 184 patients with reflux esophagitis, sucralfate suspension significantly reduced the endoscopic relapse rate to 31% compared to 65% in the placebo group (p < 0.001).

Sucralfate was particularly effective in preventing symptomatic relapses, with only 10% of patients experiencing symptoms compared to 34% in the placebo group (p < 0.001), demonstrating its efficacy in maintaining remission after initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sucralfate maintenance therapy in reflux esophagitis. Sucralfate Investigational Working Team. Tytgat, GN., Koelz, HR., Vosmaer, GD.[2004]

In a pilot study of 12 patients with severe reflux esophagitis unresponsive to standard treatments, the use of sucralfate for 8 weeks led to significant improvements in both symptoms and endoscopic appearance of the esophagus.

Complete healing of esophagitis was observed in 6 patients after 4 to 6 months of continuous sucralfate therapy, suggesting that enhancing esophageal mucosal resistance is crucial for treating refractory esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of sucralfate in refractory reflux esophagitis. Results of a pilot study. Ros, E., Pujol, A., Bordas, JM., et al.[2019]

In a study of 70 patients with reflux esophagitis, both sucralfate alone and a combination of sucralfate and cimetidine showed good symptomatic improvement and comparable healing rates after eight weeks, with no significant side effects reported.

After six months of maintenance treatment, there was no significant difference in relapse rates of esophagitis between patients receiving sucralfate and those on placebo, indicating that while sucralfate is effective for initial treatment, it may not prevent long-term relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy of sucralfate and cimetidine, compared with sucralfate monotherapy, in patients with peptic reflux esophagitis. Schotborgh, RH., Hameeteman, W., Dekker, W., et al.[2019]

Sucralfate has been shown to be an effective treatment for reflux esophagitis, with healing rates of 72% and improvement in 14% of patients, significantly better than placebo (40% healing, 20% improvement).

The efficacy of sucralfate is comparable to that of H2-receptor blockers, with similar rates of symptom relief and mucosal healing, indicating it is a safe and effective option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of sucralfate in reflux oesophagitis. Tytgat, GN.[2008]

In a study of 36 patients with severe erosive esophagitis, the combination of sucralfate suspension and cimetidine significantly improved daytime heartburn symptoms compared to cimetidine alone.

While both treatments led to endoscopic healing, the adjunctive use of sucralfate likely increased the chances of complete healing of esophagitis, although the difference in healing rates was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sucralfate used as adjunctive therapy in patients with severe erosive peptic esophagitis resulting from gastroesophageal reflux. Herrera, JL., Shay, SS., McCabe, M., et al.[2013]

In a study of 42 patients with reflux esophagitis, sucralfate showed comparable efficacy to cimetidine, with both treatments leading to significant symptomatic improvement after eight weeks.

Endoscopic results indicated that 53% of patients treated with sucralfate showed improvement, and 31% experienced healing of esophagitis, while cimetidine resulted in 67% improvement and 14% healing, suggesting sucralfate is a valid alternative to standard H2-receptor blockers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of sucralfate in reflux esophagitis. Comparison with cimetidine. Tytgat, GN.[2019]

In a study involving 68 patients with reflux esophagitis, treatment with sucralfate suspension for eight weeks did not show a significant improvement in heartburn symptoms or endoscopic healing compared to a placebo.

Despite the lack of statistically significant differences, there was a trend suggesting that sucralfate may have a beneficial effect, as 81% of patients treated with sucralfate showed healing or improvement compared to 59% with placebo, indicating further investigation may be warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter trial of sucralfate suspension for the treatment of reflux esophagitis. Williams, RM., Orlando, RC., Bozymski, EM., et al.[2019]

Sucralfate is an effective nonsystemic antiulcer medication that is primarily used for treating duodenal and gastric ulcers, but its application for caustic esophagitis had not been previously studied.

This report presents a case where sucralfate was used to treat lye-induced esophagitis, suggesting potential for its use in similar gastrointestinal injuries, although more research is needed to confirm its efficacy in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sucralfate therapy for lye-induced esophagitis. Reddy, AN., Budhraja, M.[2004]

Barrett's esophagus, which involves abnormal cell changes in the esophagus, carries a 0.5% annual risk of developing esophageal adenocarcinoma, highlighting the importance of monitoring and treatment.

While endoscopic procedures for Barrett's esophagus can lead to discomfort and dysphagia, sucralfate is commonly used post-procedure to promote healing, although its efficacy has not been clinically proven through trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Viscous Sucralfate Gel for Post-procedural Treatment of Barrett's Esophagus. Zur, E.[2019]

Citations

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Clinical efficacy of sucralfate in reflux esophagitis. ...

Endoscopy showed improvement in 53 percent of patients and healing of esophagitis in 31 percent after sucralfate treatment.

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amjmed.com

amjmed.com/article/0002-9343(87)90825-4/fulltext

Clinical efficacy of sucralfate in reflux esophagitis

Endoscopy showed improvement in 53 percent of patients and healing of esophagitis in 31 percent after sucralfate treatment.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/20533105/

The efficiency of sucralfate in corrosive esophagitis

Conclusions: Intensive sucralfate therapy may decrease the frequency of stricture formation in patients with advanced corrosive esophagitis. Further studies ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT02353078

The Effect of Sucralfate Slurry in Patients With Eosinophilic ...

Furthermore, the side effect profile of sucralfate is excellent with little systemic absorption.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/0002934387908254

Clinical efficacy of sucralfate in reflux esophagitis

Endoscopy showed improvement in 53 percent of patients and healing of esophagitis in 31 percent after sucralfate treatment.

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mayoclinic.org

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Sucralfate (oral route) - Side effects & dosage

Sucralfate is used to treat and prevent duodenal ulcers and other conditions as determined by your doctor. It works by forming a barrier or coat over the ulcer.

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Sucralfate - StatPearls - NCBI Bookshelf - NIH

Sucralfate acts locally with negligible absorption, making it relatively safe. The most common side effect is constipation, seen in 1% to 10% of patients.

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Data Sheet - Carafate - 22-Nov-2022

Four grams (4 g) daily of sucralfate is effective in increasing the rate of healing of duodenal ulcer and gastric ulcer over a period of 4 to 8 weeks. Two ...

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The liquid form of sucralfate should never be injected through a needle into the body, or death may occur.

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Sucralfate (Carafate) - Uses, Side Effects, and More

Sucralfate tablets should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to ...