Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions: 1. can this zinc administration cause molecular-level changes in the Barrett's tissue? 2. are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?
14 days prior to already-scheduled upper endoscopy (EGD) procedures for routine surveillance of Barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc BID) or a placebo (molar equivalent of sodium gluconate BID) for 14 days. At the time of endoscopy, 4 biopsies are taken (and pooled) from the Barrett's tissue and 4 from proximal normal esophageal tissue. Biopsies are flash frozen for later analyses by atomic absorption spectroscopy, PAGE and Western immunoblot or RNA microarray.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
120
26.6 mg zinc BID (as zinc gluconate)
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
RECRUITINGChanges in zinc-regulated cellular proteins within Barrett's tissue
Time frame: in biopsy tissue after 14 days of Zn exposure
Changes in cellular microRNA profile; changes in protein cancer biomarkers
Time frame: in biopsy tissue after 14 days of Zn exposure
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