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

NCT01261962 | Unknown

• 1 other identifier: FAPESP:2010/08787-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Adjuvant Chemotherapy; Colon Cancer; Immunity

Keywords

Humoral immunity; Neutrophil function; Gene expression

Outcome Measures

Primary Outcomes (1)

• Gene expression

  Modulation of genes related to immune response

  18 months

Secondary Outcomes (1)

• Humoral immunity and neutrophil function

  18 months

Study Arms (4)

Chemotherapy and zinc

EXPERIMENTAL

Patients in adjuvant chemotherapy supplemented with zinc

Dietary Supplement: zinc

Chemotherapy placebo

PLACEBO COMPARATOR

Patients in adjuvant chemotherapy with placebo

Other: Placebo

Control and zinc

OTHER

Healthy patients supplemented with zinc

Dietary Supplement: zinc

Control Placebo

OTHER

Healthy volunteers received placebo

Other: Placebo

Interventions

zinc DIETARY_SUPPLEMENT

zinc sulfate, 35 mg twice daily for 4 months

Chemotherapy and zinc; Control and zinc

Placebo OTHER

Placebo, One capsule, twice daily for 4 months

Chemotherapy placebo; Control Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Departament of Clinical Oncology, Sao Paulo University

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Zinc

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Selma Freire C. Cunha, PhD

  Sao Paulo University

  STUDY DIRECTOR

• Camila Bitu M. Braga, Msc

  Sao Paulo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camila Bitu M. Braga, Msc

CONTACT

55-16-36023369; camilabitu@usp.br

Selma Freire C. Cunha, PhD

CONTACT

55-16-36013369; sfreire@fmrp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: February 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: August 1, 2013
• Last Updated: December 17, 2010

Record last verified: 2010-12

Locations

BR (1)