Clincosm LogoSign in Get a demo

Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer

Sponsor
University of Sao Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT01261962
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
60
Enrollment
1
Location
4
Arms
30
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In leukocytes of patients undergoing adjuvant chemotherapy for colon cancer treatment:

a)identify genes modulated by oral supplementation of zinc; b) evaluate the effects of oral zinc supplementation on humoral immunity and neutrophil function. The study will be conducted on 30 adult patients aged grater than 18 years, of both genders who have undergone surgical resection of colonic neoplastic lesions without metastatic lesion. Patients will be randomized into two groups, with the first (Group QT Zn, n = 15) receive 70 mg/d of zinc for 16 weeks and the second will receive placebo (QT Placebo Group, n = 15). The study will also include 30 healthy volunteers who receive supplementation of 70 mg/d of Zn (C Zn group, n = 15) or placebo (Group C Placebo, n = 15). Zinc supplementation or placebo for all study groups will start two days before the volunteers received the pneumococcal vaccine, polyvalent 23. Fifteen days after vaccination, patients begin chemotherapy as pre-established criteria by the Oncology Service. Will be monitored the parameters of nutritional status (anthropometry, bioelectrical impedance, food intake, and laboratory tests) adverse effects, according to rules of the CTCAE. In the evaluation of humoral immunity, antibodies opsonization and in the pneumococcal polysaccharide will be measured. Will be evaluated the function of neutrophils by measuring DNA NETs and quantified calprotectin and elastase released in the culture supernatants of activated neutrophils. RT-qPCR will be done of genes differentially expressed(DEGS) on activated leukocytes. In six volunteers from each group will be analyzed global gene expression from RNA extracted from leukocytes by microarray; will be detected and correlated the molecular pathways modulated by zinc by MetaCore software (GeneGo). The DEGS will be validated by RT-qPCR.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: zinc
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Modulation of Immune Response by Oral Zinc Supplementation in Adjuvant Chemotherapy for Colon Cancer: a Study of Global Gene Expression and Function of Humoral Immunity and Neutrophils
Study Start Date :
Feb 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chemotherapy and zinc

Patients in adjuvant chemotherapy supplemented with zinc

Dietary Supplement: zinc
zinc sulfate, 35 mg twice daily for 4 months
Placebo Comparator: Chemotherapy placebo

Patients in adjuvant chemotherapy with placebo

Other: Placebo
Placebo, One capsule, twice daily for 4 months
Other: Control and zinc

Healthy patients supplemented with zinc

Dietary Supplement: zinc
zinc sulfate, 35 mg twice daily for 4 months
Other: Control Placebo

Healthy volunteers received placebo

Other: Placebo
Placebo, One capsule, twice daily for 4 months

Outcome Measures

Primary Outcome Measures

  1. Gene expression [18 months]

    Modulation of genes related to immune response

Secondary Outcome Measures

  1. Humoral immunity and neutrophil function [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Age greater than 18 years

  • Diagnostic histopathology of colon cancer stage III (Dukes' stage C)

  • Performance Scale Karnofsky greater or equal to 70%

  • Have been subjected to resection of the primary neoplastic lesion in more than 8 weeks before start of chemotherapy

  • Patient in the first cycle of chemotherapy in adjuvant XELOX regimen.

Exclusion Criteria:

  • Patients with a history of autoimmune or inflammatory disease, active infectious disease, liver disease, renal failure or diabetes mellitus

  • Patients with metastatic disease

  • Have previously received radiotherapy or chemotherapy

  • Use of GCSF-Granulokine ® (growth-stimulating factor granulocyte)

  • Use of immunosuppressive drugs, diuretics and supplements of zinc or copper.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Departament of Clinical Oncology, Sao Paulo University Ribeirao Preto Sao Paulo Brazil 14049-900

Sponsors and Collaborators

  • University of Sao Paulo
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Director: Selma Freire C. Cunha, PhD, Sao Paulo University
  • Principal Investigator: Camila Bitu M. Braga, Msc, Sao Paulo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01261962
Other Study ID Numbers:
  • FAPESP:2010/08787-1
First Posted:
Dec 17, 2010
Last Update Posted:
Dec 17, 2010
Last Verified:
Dec 1, 2010
Keywords provided by , ,
Humoral immunity
Neutrophil function
Gene expression
Additional relevant MeSH terms:
Colonic Neoplasms

Study Results

No Results Posted as of Dec 17, 2010