Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Adjuvant Chemotherapy Colon Cancer Immunity |
Dietary Supplement: zinc Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
- Gene expression [ Time Frame: 18 months ] [ Designated as safety issue: No ]Modulation of genes related to immune response
- Humoral immunity and neutrophil function [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Chemotherapy and zinc
Patients in adjuvant chemotherapy supplemented with zinc
|
Dietary Supplement: zinc
zinc sulfate, 35 mg twice daily for 4 months
|
|
Placebo Comparator: Chemotherapy placebo
Patients in adjuvant chemotherapy with placebo
|
Other: Placebo
Placebo, One capsule, twice daily for 4 months
|
|
Control and zinc
Healthy patients supplemented with zinc
|
Dietary Supplement: zinc
zinc sulfate, 35 mg twice daily for 4 months
|
|
Control Placebo
Healthy volunteers received placebo
|
Other: Placebo
Placebo, One capsule, twice daily for 4 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Camila Bitu M. Braga, Msc | 55-16-36023369 | camilabitu@usp.br |
| Contact: Selma Freire C. Cunha, PhD | 55-16-36013369 | sfreire@fmrp.usp.br |
| Brazil | |
| Departament of Clinical Oncology, Sao Paulo University | Not yet recruiting |
| Ribeirao Preto, Sao Paulo, Brazil, 14049-900 | |
| Contact: Camila Bitu M. Braga, Msc 55-16-36023369 camilabitu@usp.br | |
| Contact: Selma Freire C. Cunha, PhD 55-16-36023369 sfreire@fmrp.usp.br | |
| Sub-Investigator: Fernanda Maris Peria, PhD | |
| Principal Investigator: Camila Bitu M. Braga, Msc | |
| Study Director: | Selma Freire C. Cunha, PhD | Sao Paulo University |
| Principal Investigator: | Camila Bitu M. Braga, Msc | Sao Paulo University |
More Information
No publications provided
| Responsible Party: | Selma Freire de Carvalho da Cunha, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01261962 History of Changes |
| Other Study ID Numbers: | FAPESP:2010/08787-1 |
| Study First Received: | December 16, 2010 |
| Last Updated: | December 16, 2010 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo:
|
Humoral immunity Neutrophil function Gene expression |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Zinc Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013