Status:
UNKNOWN
Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Adjuvant Chemotherapy
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01261962
Start Date
February 1 2011
End Date
August 1 2013
Last Update
December 17 2010
Active Locations (1)
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1
Departament of Clinical Oncology, Sao Paulo University
Ribeirão Preto, São Paulo, Brazil, 14049-900