This randomized phase II studies how well zinc sulfate works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc sulfate may help to improve patient's quality of life by preventing zinc deficiency.
Additional locations may be listed on ClinicalTrials.gov for NCT03819088.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.
SECONDARY OBJECTIVES:
I. Correlate hypoalbuminemia with serum zinc deficiency.
II. Correlate zinc deficiency with neutropenia.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive zinc sulfate orally (PO) thrice daily (TID) for months 1 and 2 only of the first 4 months on therapy. Patients also undergo collection of blood samples at screening and on study.
GROUP II: Patients receive zinc sulfate orally (PO) TID for months 3 and 4 only of the first 4 months on therapy. Patients also undergo collection of blood samples at screening and on study.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorOlatunji B. Alese
