Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03819088
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Edith Brutcher, Emory University

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 Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : April 17, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021


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 Name: 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 Name: Zinc sulfate




Primary Outcome Measures :
  1. Quality of life scores [ Time Frame: 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 :
  1. Serum zinc level [ Time Frame: 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.

  2. Serum albumin level [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Exclusion from trial if zinc level is 1.5 x greater then upper limit of normal (ULN) at baseline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819088


Contacts
Layout table for location contacts
Contact: Edith Brutcher, MSN 404-778-2670 edith.brutcher@emoryhealthcare.org

Locations
Layout table for location information
United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sheena Abraham    404-778-2670    sheena.abraham@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Edith Brutcher, MSN Emory University

Layout table for additonal information
Responsible Party: Edith Brutcher, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT03819088     History of Changes
Other Study ID Numbers: IRB00099791
NCI-2017-02467 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Winship4173-17 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan may be reevaluated at the time of publication.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Esophageal Diseases
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma
Carcinoma, Ductal
Cholangiocarcinoma
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Stomach Diseases
Adenocarcinoma
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Astringents