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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Sao Paulo.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01261962
First received: December 16, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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 Intervention
Adjuvant Chemotherapy
Colon Cancer
Immunity
Dietary Supplement: zinc
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Gene expression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Modulation of genes related to immune response


Secondary Outcome Measures:
  • Humoral immunity and neutrophil function [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Control and zinc
Healthy patients supplemented with zinc
Dietary Supplement: zinc
zinc sulfate, 35 mg twice daily for 4 months
Control Placebo
Healthy volunteers received placebo
Other: Placebo
Placebo, One capsule, twice daily for 4 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261962

Contacts
Contact: Camila Bitu M. Braga, Msc 55-16-36023369 camilabitu@usp.br
Contact: Selma Freire C. Cunha, PhD 55-16-36013369 sfreire@fmrp.usp.br

Locations
Brazil
Departament of Clinical Oncology, Sao Paulo University Not yet recruiting
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Contact: Camila Bitu M. Braga, Msc    55-16-36023369    camilabitu@usp.br   
Contact: Selma Freire C. Cunha, PhD    55-16-36023369    sfreire@fmrp.usp.br   
Sub-Investigator: Fernanda Maris Peria, PhD         
Principal Investigator: Camila Bitu M. Braga, Msc         
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
  More Information

No publications provided

Responsible Party: Selma Freire de Carvalho da Cunha, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01261962     History of Changes
Other Study ID Numbers: FAPESP:2010/08787-1
Study First Received: December 16, 2010
Last Updated: December 16, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Humoral immunity
Neutrophil function
Gene expression

Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 20, 2014