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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


N/A
18 Years
N/A
Not Enrolling
Both
Adjuvant Chemotherapy, Colon Cancer, Immunity

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Gene expression

Outcome Description:

Modulation of genes related to immune response

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Selma Freire C. Cunha, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Sao Paulo University

Authority:

Brazil: Ethics Committee

Study ID:

FAPESP:2010/08787-1

NCT ID:

NCT01261962

Start Date:

February 2011

Completion Date:

August 2013

Related Keywords:

  • Adjuvant Chemotherapy
  • Colon Cancer
  • Immunity
  • Humoral immunity
  • Neutrophil function
  • Gene expression
  • Colonic Neoplasms

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