Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adjuvant Chemotherapy; Colon Cancer; Immunity
Intervention: zinc (Dietary Supplement); Placebo (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s): Selma Freire C. Cunha, PhD, Study Director, Affiliation: Sao Paulo University Camila Bitu M. Braga, Msc, Principal Investigator, Affiliation: Sao Paulo University
Overall contact: Camila Bitu M. Braga, Msc, Phone: 55-16-36023369, Email: camilabitu@usp.br
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Gene expression
Secondary outcome: Humoral immunity and neutrophil function
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Camila Bitu M. Braga, Msc, Phone: 55-16-36023369, Email: camilabitu@usp.br
Departament of Clinical Oncology, Sao Paulo University, Ribeirao Preto, Sao Paulo 14049-900, Brazil; Not yet recruiting Camila Bitu M. Braga, Msc, Phone: 55-16-36023369, Email: camilabitu@usp.br Selma Freire C. Cunha, PhD, Phone: 55-16-36023369, Email: sfreire@fmrp.usp.br Fernanda Maris Peria, PhD, Sub-Investigator Camila Bitu M. Braga, Msc, Principal Investigator
Additional Information
Starting date: February 2011
Last updated: December 16, 2010
|