<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02248584</url>
  </required_header>
  <id_info>
    <org_study_id>Betania</org_study_id>
    <nct_id>NCT02248584</nct_id>
  </id_info>
  <brief_title>VITAMIN E, C and ZINC IN PATIENTS WITH SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE</brief_title>
  <official_title>SUPPLEMENTATION OF VITAMIN E, C and ZINC IN PATIENTS WITH NON-MELANOMA SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campinas, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campinas, Brazil</source>
  <brief_summary>
    <textblock>
      The objective of this study was to evaluate the effects of supplementary antioxidant therapy&#xD;
      on the levels of biomarkers and inflamatory citocines in patients with a previous history of&#xD;
      non-melanoma skin cancer treated with surgery. This was a double-blind, randomized,&#xD;
      placebo-controlled trial. Patients were randomized into two groups, one receiving placebo&#xD;
      (n=34) and the other receiving supplementary antioxidant therapy (n=26) with vitamin C (50&#xD;
      mg), vitamin E (60 mg), and zinc (40 mg) for 60 days. Blood samples were obtained from&#xD;
      patients, and the levels of oxidative stress biomarkers, including 8-isoprostane, nitrite,&#xD;
      thiobarbituric acid reactive substances, and total antioxidant capacity, were measured, as&#xD;
      well as the inflamatory citocines (IL-1, IL-6, IL-10, TNF alfa) and it was evaluated at two&#xD;
      different times: (1) one day before the start of supplementation or placebo administration&#xD;
      and (2) at 60 days after intervention. Statistical analyses were performed with the SAS&#xD;
      System for Windows 9.3 program and data were analyzed using ANOVA for repeated measures test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>OXIDATIVE STRESS BIOMARKERS</measure>
    <time_frame>one day before the start of supplementation or placebo administration and at 60 days after intervention</time_frame>
    <description>8-isoprostane, Thiobarbituric Acid Reactive Substances (TBARS), Nitrite, Total Antioxidant Capacity (TAC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>INFLAMMATORY STATE</measure>
    <time_frame>one day before the start of supplementation or placebo administration and at 60 days after intervention</time_frame>
    <description>IL-1, IL-6, IL-10, TNF alfa</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Skin Neoplasms</condition>
  <arm_group>
    <arm_group_label>Vitamin E, C and Zinc</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsule containing vitamin C (50 mg; CVS Quality, USA), vitamin E (60 mg; Nature´s Bounty, USA), and zinc (40 mg; CVS Quality, USA) per day for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsule containing only lactose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin C, E and Zinc</intervention_name>
    <description>Capsule containing vitamin C (50 mg; CVS Quality, USA), vitamin E (60 mg; Nature´s Bounty, USA), and zinc (40 mg; CVS Quality, USA) per day for 60 days.</description>
    <arm_group_label>Vitamin E, C and Zinc</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who had non-melanoma skin cancer (squamous cell carcinoma or basal cell&#xD;
             carcinoma) and who were treated with surgery&#xD;
&#xD;
          -  age ≥20 years&#xD;
&#xD;
          -  absence of comorbidities such as type 1 diabetes, severe heart disease, hepatic&#xD;
             dysfunction, renal failure requiring dialysis, HIV infection, and melanoma skin cancer&#xD;
&#xD;
          -  no history of chemotherapy or radiotherapy in the previous 6 months&#xD;
&#xD;
          -  absence of severe psychiatric disease that limited comprehension&#xD;
&#xD;
          -  not taking any vitamin and/or mineral supplementation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects did not complete the entire course of supplemental therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Patricia Moriel</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02248584
org study id: Betania
nct id: NCT02248584
lead sponsor: 
The objective of this study was to evaluate the effects of supplementary antioxidant therapy
      on the levels of biomarkers and inflamatory citocines in patients with a previous history of
      non-melanoma skin cancer treated with surgery. This was a double-blind, randomized,
      placebo-controlled trial. Patients were randomized into two groups, one receiving placebo
      (n=34) and the other receiving supplementary antioxidant therapy (n=26) with vitamin C (50
      mg), vitamin E (60 mg), and zinc (40 mg) for 60 days. Blood samples were obtained from
      patients, and the levels of oxidative stress biomarkers, including 8-isoprostane, nitrite,
      thiobarbituric acid reactive substances, and total antioxidant capacity, were measured, as
      well as the inflamatory citocines (IL-1, IL-6, IL-10, TNF alfa) and it was evaluated at two
      different times: (1) one day before the start of supplementation or placebo administration
      and (2) at 60 days after intervention. Statistical analyses were performed with the SAS
      System for Windows 9.3 program and data were analyzed using ANOVA for repeated measures test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: OXIDATIVE STRESS BIOMARKERS
time frame: one day before the start of supplementation or placebo administration and at 60 days after intervention
description: 8-isoprostane, Thiobarbituric Acid Reactive Substances (TBARS), Nitrite, Total Antioxidant Capacity (TAC)
measure: INFLAMMATORY STATE
time frame: one day before the start of supplementation or placebo administration and at 60 days after intervention
description: IL-1, IL-6, IL-10, TNF alfa
arm group label: Vitamin E, C and Zinc
arm group type: Experimental
description: Capsule containing vitamin C (50 mg; CVS Quality, USA), vitamin E (60 mg; Nature´s Bounty, USA), and zinc (40 mg; CVS Quality, USA) per day for 60 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Capsule containing only lactose
intervention type: Dietary Supplement
intervention name: Vitamin C, E and Zinc
description: Capsule containing vitamin C (50 mg; CVS Quality, USA), vitamin E (60 mg; Nature´s Bounty, USA), and zinc (40 mg; CVS Quality, USA) per day for 60 days.
arm group label: Vitamin E, C and Zinc
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Patricia Moriel
investigator title: PhD
mesh term: Skin Neoplasms