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

NCT ID: NCT01261962

Last Updated: 2010-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adjuvant Chemotherapy Colon Cancer Immunity

Keywords

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Humoral immunity Neutrophil function Gene expression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chemotherapy and zinc

Patients in adjuvant chemotherapy supplemented with zinc

Group Type EXPERIMENTAL

zinc

Intervention Type DIETARY_SUPPLEMENT

zinc sulfate, 35 mg twice daily for 4 months

Chemotherapy placebo

Patients in adjuvant chemotherapy with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo, One capsule, twice daily for 4 months

Control and zinc

Healthy patients supplemented with zinc

Group Type OTHER

zinc

Intervention Type DIETARY_SUPPLEMENT

zinc sulfate, 35 mg twice daily for 4 months

Control Placebo

Healthy volunteers received placebo

Group Type OTHER

Placebo

Intervention Type OTHER

Placebo, One capsule, twice daily for 4 months

Interventions

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zinc

zinc sulfate, 35 mg twice daily for 4 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo, One capsule, twice daily for 4 months

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of Sao Paulo

Principal Investigators

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Selma Freire C. Cunha, PhD

Role: STUDY_DIRECTOR

Sao Paulo University

Camila Bitu M. Braga, Msc

Role: PRINCIPAL_INVESTIGATOR

Sao Paulo University

Locations

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Departament of Clinical Oncology, Sao Paulo University

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Camila Bitu M. Braga, Msc

Role: CONTACT

Phone: 55-16-36023369

Email: [email protected]

Selma Freire C. Cunha, PhD

Role: CONTACT

Phone: 55-16-36013369

Email: [email protected]

Facility Contacts

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Camila Bitu M. Braga, Msc

Role: primary

Selma Freire C. Cunha, PhD

Role: backup

Other Identifiers

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FAPESP:2010/08787-1

Identifier Type: -

Identifier Source: org_study_id