Barrett's Esophagus | Melatonin Associated to Acid Inhibition for Chemoprevention in Barret Esophagus: a Pilot Study
Barrett's Esophagus research study
What is the primary objective of this study?
The study consists on determining whether melatonin decreases oxidative stress in Barrett's esophageal mucosa after 6 months of treatment. In order to achieve the clinical trial, the patients will be randomized to two possible arms: omeprazole alone or omeprazole plus melatonin. The patients will be followed around four visits during six months. GERD is one of the most prevalent pathologies in the digestive tract. Barrett's esophagus, a complication of chronic GERD, has attracted the attention of researchers due to its condition of pre-neoplastic lesion. At present, treatment of Barrett's patients is limited to acid inhibition with PPIs. Although there are several studies which indicate that treatment with PPIs could decrease the incidence of high grade dysplasia and EAC, treatment with PPIs does not eliminate the risk of EAC in these patients. Therefore, it is necessary to find chemo-preventive agents that stop neoplastic progression of Barrett's esophagus. Among them, antioxidants have become the most promising agent. This pilot study will determine the efficacy of melatonin in the chemoprevention of EAC. So, the main objective of this study is to determine whether melatonin decreases oxidative stress in Barrett's esophageal mucosa after 6 months of treatment. To evaluate whether melatonin modifies other mechanisms associated to neoplastic progression in BE patients: proliferation and apoptotic index and molecular markers of progression: 17pLOH, 9pLOH, p16 methylation and DNA ploidy (tetraploidy and/or aneuploidy).
Who is eligible to participate?
Inclusion Criteria: - Patients (males and females) with Barrett's esophagus (>18 years and <80) without macroscopic esophagitis at endoscopy and a length of the metaplasic mucosa of 2 cm or longer, who agree to participate in the study. Exclusion Criteria: - Presence of carcinoma or high grade dysplasia at basal endoscopy. - Previous gastric or esophageal surgery. - Patients on NSAID or aspirin treatment. A maximum of 5 days per month is allowed. Paracetamol will be used as the standard analgesic treatment. - Neoplastic malignancies. - Hematological serious diseases. Coagulation disorders and anemia with Hb < 9.5 gr/dL. - Serious/moderate cardiac, liver or renal diseases. - Need of corticosteroid therapy. A minimum of 5 days per month is allowed, as well as topical or inhaled treatment. - Patients on misoprostol or anticoagulants. - Patients with inflammatory bowel disease. - Allergy to investigational drugs.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:OmeprazoleOmeprazole 40 mg/day alone. Patients will take the capsule once in the morning before breakfast. This is the standard therapy for patients suffering from Barrett's esophagus.
Drug:MelatoninOmeprazole 40 mg/day + Circadin 6 mg/12 hours. Patients will take the Omeprazole capsule once in the morning before breakfast together with 3 tables of 2 mgs of Circadin (melatonin). In the evening, before dinner, patients will take 3 tablets of 2 mg of Circadin.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Melatonin + omeprazoleOmeprazole 40 mg/day + Circadin 6 mg/12 hours. Patients will take the Omeprazole capsule once in the morning before breakfast together with 3 tables of 2 mgs of Circadin (melatonin). In the evening, before dinner, patients will take 3 tablets of 2 mg of Circadin.
omeprazoleOmeprazole 40 mg/day alone. Patients will take the capsule once in the morning before breakfast. This is the standard therapy for patients suffering from Barrett's esophagus.
Start Date: April 2012
Completed Date: April 2013
Phase: Phase 3
Primary Outcome: Oxidative stress
Secondary Outcome: Biological markers of diseases progression
Study sponsors, principal investigator, and references
Principal Investigator: Angel Lanas Arbeloa, Physician
Lead Sponsor: Aragon Institute of Health Sciences