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

Sponsor

Emory University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03819088

Collaborator

(none)

Enrollment

Locations

Arms

51.6

Anticipated Duration (Months)

8.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Carcinoma Liver and Intrahepatic Bile Duct Carcinoma Unresectable Esophageal Carcinoma Unresectable Pancreatic Carcinoma	Dietary Supplement: Zinc	N/A

Detailed Description

PRIMARY OBJECTIVE:

Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.

SECONDARY OBJECTIVES:

Correlate hypoalbuminemia with serum zinc deficiency.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 17, 2019

Anticipated Primary Completion Date :

Mar 22, 2023

Anticipated Study Completion Date :

Aug 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I (zinc months 1 and 2) Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.	Dietary Supplement: Zinc Given PO Other Names: Zinc sulfate
Experimental: Group II (zinc months 3 and 4) Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.	Dietary Supplement: Zinc Given PO Other Names: Zinc sulfate

Arm

Intervention/Treatment

Experimental: Group I (zinc months 1 and 2)

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

Dietary Supplement: Zinc

Given PO

Other Names:

Zinc sulfate

Experimental: Group II (zinc months 3 and 4)

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

Dietary Supplement: Zinc

Given PO

Other Names:

Zinc sulfate

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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