Melatonin Associated to Acid Inhibition for Chemoprevention in Barret Esophagus: a Pilot Study
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
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).