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

Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03819088

Enrollment

Registered

2019-01-28

Start date

2019-04-17

Completion date

2022-03-22

Last updated

2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Unresectable Esophageal Carcinoma, Unresectable Pancreatic Carcinoma

Brief summary

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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTZinc

Given PO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of life scores	Up to 4 months after study start	Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey.

Secondary

Measure	Time frame	Description
Serum zinc level	Up to 4 months after study start	Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg.
Serum albumin level	Up to 4 months after study start	Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026