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

Gastric Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819088
• Other study ID #: IRB00099791
• Secondary ID: NCI-2017-02467Wi
• Status: Completed
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: October 5, 2021

Study information

• Verified date: January 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 5, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Neoplasms
• Gastric Carcinoma
• Liver and Intrahepatic Bile Duct Carcinoma
• Pancreatic Neoplasms
• Stomach Neoplasms
• Unresectable Esophageal Carcinoma
• Unresectable Pancreatic Carcinoma

Intervention

Dietary Supplement:
• Zinc
Given PO

Locations

Country	Name	City	State
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life scores	Quality of life (QOL) will be evaluated through patient subjective responses to the QOL survey.	Up to 4 months after study start
Secondary	Serum zinc level	Zinc levels will be monitored monthly with blood tests. Low zinc will be defined as under 60 mcg.	Up to 4 months after study start
Secondary	Serum albumin level	Albumin levels will be monitored monthly with blood tests. Low albumin will be defined as under 3.5 gm/dl.	Up to 4 months after study start