Study on Budesonide Tablets for Preventing Esophageal Narrowing in Adults After Cancer Tissue Removal

What is this study about?

This clinical trial is focused on preventing a condition called esophageal strictures, which are narrowings in the esophagus that can occur after a procedure known as endoscopic submucosal dissection. This procedure is often used to remove cancerous or pre-cancerous tissue from the esophagus. The study is testing the effectiveness and safety of a medication called budesonide, which is taken as an effervescent tablet that dissolves in the mouth. Budesonide is being compared to a placebo, which is a tablet that looks like the medication but does not contain any active ingredients.

The purpose of the study is to see if taking budesonide for eight weeks can help prevent the formation of esophageal strictures in adults who have undergone the endoscopic procedure. Participants in the study will be randomly assigned to receive either a low dose or a high dose of budesonide, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the doctors will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not influenced by expectations about the treatment.

Throughout the study, participants will take the medication or placebo for a total of eight weeks. The main goal is to determine how many participants remain free of esophageal strictures by the end of the study period. Additionally, the study will track the number of times participants need a procedure called endoscopic dilation, which is used to widen the esophagus if strictures do occur. The results will help determine if budesonide is an effective treatment for preventing esophageal strictures after endoscopic submucosal dissection.

1 joining the study

Upon joining the study, the patient must provide a signed informed consent.

Eligibility criteria include being between 18 to 85 years old, having an estimated life expectancy of at least one year, and an ECOG Performance Status of 2 or less after the endoscopic procedure.

Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control methods during the trial.

2 randomization

The patient is randomly assigned to one of the treatment groups. This means the treatment group is determined by chance, and neither the patient nor the physician knows which group the patient is in.

3 treatment phase

The patient receives an 8-week treatment with either budesonide orodispersible tablets or a placebo.

The dosage of budesonide is either 2 x 1 mg per day or 2 x 2 mg per day, taken orally as effervescent tablets.

4 monitoring and assessments

Throughout the treatment phase, the patient’s condition is monitored to assess the efficacy of the treatment in preventing oesophageal strictures.

The primary goal is to determine the percentage of patients free of strictures at the 8-week visit.

5 follow-up

After the treatment phase, follow-up visits are conducted to evaluate the long-term effects of the treatment.

Secondary assessments include the number of endoscopic dilations required and the percentage of patients free of strictures until the follow-up visit.

Who Can Join the Study?

Must provide a signed informed consent, which means you agree to participate after understanding the study.
Must be a male or female aged between 18 and 85 years.
Must have an estimated life expectancy of at least one year.
Must have an ECOG Performance Status of 2 or less. This is a scale that measures your ability to perform daily activities, with lower numbers indicating better function.
Must have had a biopsy or endoscopic examination showing certain conditions in the esophagus, such as oesophageal SCC (a type of cancer) or high-grade dysplasia (abnormal cells), and have been treated with a procedure called ESD (endoscopic submucosal dissection).
Must have a mucosal defect after ESD that covers at least 50% of the esophagus if you have SCC, or at least 75% if you have other specific conditions like BE-HGD or EAC.
If you are a female who can become pregnant, you must have a negative pregnancy test at the start of the study.
Women who can become pregnant must agree to use effective birth control methods throughout the study. These methods include implants, injections, birth control pills, patches, vaginal rings, copper IUDs, abstinence, or having a partner who has had a vasectomy. The study doctor will help determine if your birth control method is suitable.
Women who cannot become pregnant can participate if they are surgically sterile (have had a tubal ligation or hysterectomy) or are post-menopausal (have not had a period for at least two years).

Who Cannot Join the Study?

Patients who are not adults cannot participate.
Patients who have not undergone an endoscopic submucosal dissection cannot participate. This is a procedure where a thin layer of tissue is removed from the esophagus using a special tool.
Patients who are unable to take the study medication as prescribed cannot participate.
Patients with any medical condition that might interfere with the study or pose a risk to their health cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are participating in another clinical trial cannot participate.
Patients with a history of severe allergic reactions to the study medication cannot participate.
Patients who have a condition that affects their ability to understand or follow study instructions cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Pomeranian Medical University	Szczecin	Poland
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Robert Bosch Gesellschaft fuer medizinische Forschung mbH	Stuttgart	Germany
Evangelisches Krankenhaus Duesseldorf	Duesseldorf	Germany
Karolinska University Hospital	Solna	Sweden
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH	Regensburg	Germany
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Uzvqjrqsgb Michmyb Cunhyd Hiyjjgqmhnjgposki	Hamburg	Germany
Gxpuphcsnuyrgmhuukdbxozy Sldzufxesylnxmeoeamxlzlodvduvaauqe gdsju	Bonn	Germany
Ahxkhcvna Uop	Amsterdam	The Netherlands
Eodcjzm Umzrongggqmf Makpcsc Ckjixrq Robcepusb (rjsvlaq Mth	Rotterdam	The Netherlands
Nqlcaipx Ikipnima Okxvknqpc Iac Mhmdh Ssxewohxcgnvkxiwyylxfdniiybo Icjiynrt Bzactufk	Cracow	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	13.05.2020
Germany	Not recruiting	13.05.2020
Poland	Not recruiting	13.05.2020
Portugal	Not recruiting	13.05.2020
Spain	Not recruiting	13.05.2020
Sweden	Not recruiting	13.05.2020
The Netherlands	Not recruiting	13.05.2020

Trial locations

Investigated drugs:

Budesonide

Budesonide is a medication used in this trial in the form of orodispersible tablets. It is being tested for its ability to prevent the formation of oesophageal strictures, which are narrowings of the esophagus that can occur after a procedure called endoscopic submucosal dissection. The trial aims to determine how effective and tolerable budesonide is when taken for eight weeks.

Investigated diseases:

Esophageal Stricture – This condition involves the narrowing of the esophagus, which can lead to difficulty swallowing and discomfort. It often occurs as a result of injury or inflammation, such as after an endoscopic procedure like submucosal dissection. Over time, scar tissue can form, causing the esophagus to become constricted. This narrowing can make it challenging for food and liquids to pass through smoothly. Patients may experience symptoms like a sensation of food being stuck, pain when swallowing, or unintentional weight loss. The progression of esophageal strictures can vary, with some individuals experiencing more frequent or severe symptoms than others.

Trial ID:

2023-507897-42-00

Protocol code:

BUL-5/ESD

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Budesonide Tablets for Preventing Esophageal Narrowing in Adults After Cancer Tissue Removal

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