Symptoms and General Pathology

All Conditions

Immune System Diseases

Syndrome

Immunologic Deficiency Syndromes

The goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immunodeficiency diseases or cancer. In vitro assays and in vivo skin tests and immunization with antigens will be utilized.

Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System

National Cancer Institute (NCI)

Neoplasms

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Dermatologic Agents

All Drugs and Chemicals

Micronutrients

Herbal and Botanical

Zinc Sulfate

Zinc

Cola

Patients in adjuvant chemotherapy supplemented with zinc

Patients in adjuvant chemotherapy with placebo

zinc sulfate, 35 mg twice daily for 4 months

zinc

Placebo, One capsule, twice daily for 4 months

Placebo

Camila Bitu M. Braga, Msc

Selma Freire C. Cunha, PhD

Fernanda Maris Peria, PhD

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.

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

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

Modulation of genes related to immune response

Fundação de Amparo à Pesquisa do Estado de São Paulo

University of Sao Paulo

Selma Freire de Carvalho da Cunha

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System	NCT00001158	Immunologic Def... Neoplasms		-	National Institutes of Health Clinical Center (CC)
Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer	NCT01261962	Adjuvant Chemot... Colon Cancer Immunity	zinc Placebo	18 Years -	University of Sao Paulo
Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System	NCT00001158	Immunologic Def... Neoplasms		-	National Institutes of Health Clinical Center (CC)
Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer	NCT01261962	Adjuvant Chemot... Colon Cancer Immunity	zinc Placebo	18 Years -	University of Sao Paulo

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