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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01261962
• Other study ID #: FAPESP:2010/08787-1
• Status: Not yet recruiting
• Phase: N/A
• First received: December 16, 2010
• Last updated: December 16, 2010
• Start date: February 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2010
• Source: University of Sao Paulo
• Contact: Camila Bitu M. Braga, Msc
• Phone: 55-16-36023369
• Email: camilabitu[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Colon Cancer
• Immunity

Intervention

Dietary Supplement:
• zinc
zinc sulfate, 35 mg twice daily for 4 months

Other:
• Placebo
Placebo, One capsule, twice daily for 4 months

Locations

Country	Name	City	State
Brazil	Departament of Clinical Oncology, Sao Paulo University	Ribeirao Preto	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression	Modulation of genes related to immune response	18 months	No
Secondary	Humoral immunity and neutrophil function		18 months	Yes