Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer

Emory University

Status: Completed

Conditions: Unresectable Pancreatic Carcinoma; Gastric Carcinoma; Liver and Intrahepatic Bile Duct Carcinoma; Unresectable Esophageal Carcinoma

Treatments: Dietary Supplement: Zinc

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03819088

P30CA138292 (U.S. NIH Grant/Contract)

Winship4173-17 (Other Identifier)

IRB00099791

NCI-2017-02467 (Registry Identifier)

Details and patient eligibility

About

This randomized study examines how well zinc works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc deficiency.

Full description

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 orally (PO) thrice daily (TID) for months 1 and 2 only of the first 4 months on therapy.

GROUP II: Patients receive zinc orally (PO) TID for months 3 and 4 only of the first 4 months on therapy.

Enrollment: 17 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who present to adult medical oncology outpatient clinic with new diagnosis of non-resectable gastric, gastro-esophageal, pancreas or biliary cancer
• Patients plan to receive chemotherapy at an Emory Cancer Center
• No prior chemotherapy or radiation therapy for newly diagnosed gastric, gastro-esophageal, pancreas or biliary cancer
• Patients must sign informed consent

Exclusion criteria

• Zinc supplementation is not indicated for pregnant or lactating women therefore, this is an exclusion criteria and women of childbearing age will complete a pregnancy test

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Group I (zinc months 1 and 2)

Experimental group

Description:

Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.

Treatment:

Dietary Supplement: Zinc

Group II (zinc months 3 and 4)

Experimental group

Description:

Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.

Treatment:

Dietary Supplement: Zinc