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

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ClinicalTrials.gov Identifier: NCT03819088
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Edith Brutcher, Emory University

Tracking Information
First Submitted Date  ICMJE January 25, 2019
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date July 19, 2019
Actual Study Start Date  ICMJE April 17, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03819088 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer
Official Title  ICMJE Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Gastric Carcinoma
  • Liver and Intrahepatic Bile Duct Carcinoma
  • Unresectable Esophageal Carcinoma
  • Unresectable Pancreatic Carcinoma
Intervention  ICMJE Dietary Supplement: Zinc
Given PO
Other Name: Zinc sulfate
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Zinc
  • 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.
    Intervention: Dietary Supplement: Zinc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edith Brutcher, MSN 404-778-2670 edith.brutcher@emoryhealthcare.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03819088
Other Study ID Numbers  ICMJE IRB00099791
NCI-2017-02467 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Winship4173-17 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Plan may be reevaluated at the time of publication.
Responsible Party Edith Brutcher, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edith Brutcher, MSN Emory University
PRS Account Emory University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP