Adjuvant ChemotherapyNCT01261962
Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer
A study testing zinc in people with Adjuvant Chemotherapy and Colon Cancer, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adjuvant Chemotherapy, Colon Cancer, Immunity
- What is being tested?
- zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Departament of Clinical Oncology, Sao Paulo University
Ribeirão Preto, São Paulo, 14049-900
Camila Bitu M. Braga, Msc, 55-16-36023369, camilabitu@usp.br
Selma Freire C. Cunha, PhD, 55-16-36023369, sfreire@fmrp.usp.br
About this study
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
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
- Being tested
- zinc, Placebo
- Keywords
- Humoral immunity, Neutrophil function, Gene expression
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zincDietary supplement
zinc sulfate, 35 mg twice daily for 4 months
PlaceboOther
Placebo, One capsule, twice daily for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy and zinc | Experimental | Patients in adjuvant chemotherapy supplemented with zinc Receives: Dietary Supplement: zinc |
| Chemotherapy placebo | Placebo comparator | Patients in adjuvant chemotherapy with placebo Receives: Other: Placebo |
| Control and zinc | Other | Healthy patients supplemented with zinc Receives: Dietary Supplement: zinc |
| Control Placebo | Other | Healthy volunteers received placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression
Modulation of genes related to immune response
Measured: 18 months
Secondary outcomes (1)
Humoral immunity and neutrophil function
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionDec 2011 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjuvant ChemotherapyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Selma Freire C. Cunha, PhD, Study director, Sao Paulo UniversityCamila Bitu M. Braga, Msc, Principal investigator, Sao Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261962
- Sponsor's protocol ID
- FAPESP:2010/08787-1
- Status last verified
- Dec 2010
- First submitted
- 16 Dec 2010
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01261962
- Acronym / sponsor ID
- FAPESP:2010/08787-1
- Conditions
- Adjuvant Chemotherapy, Colon Cancer, Immunity
- Keywords
- Humoral immunity, Neutrophil function, Gene expression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy and zinc | Experimental | Dietary Supplement: zincPatients in adjuvant chemotherapy supplemented with zinc |
| Chemotherapy placebo | Placebo comparator | Other: PlaceboPatients in adjuvant chemotherapy with placebo |
| Control and zinc | Other | Dietary Supplement: zincHealthy patients supplemented with zinc |
| Control Placebo | Other | Other: PlaceboHealthy volunteers received placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinczinc sulfate, 35 mg twice daily for 4 months | Dietary supplement | Chemotherapy and zinc, Control and zinc |
| PlaceboPlacebo, One capsule, twice daily for 4 months | Other | Chemotherapy placebo, Control Placebo |
Primary outcome
Gene expression
Time frame: 18 months
Modulation of genes related to immune response
1 secondary outcome
Humoral immunity and neutrophil function
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selma Freire C. Cunha, PhD study director
Sao Paulo University
Camila Bitu M. Braga, Msc principal investigator
Sao Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zinc in people with Adjuvant Chemotherapy and Colon Cancer, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camila Bitu M. Braga, Msc (55-16-36023369, camilabitu@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2010.