search
Back to results

VITAMIN E, C and ZINC IN PATIENTS WITH SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE

Primary Purpose

Skin Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin C, E and Zinc
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Neoplasms

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients who had non-melanoma skin cancer (squamous cell carcinoma or basal cell carcinoma) and who were treated with surgery
  • age ≥20 years
  • absence of comorbidities such as type 1 diabetes, severe heart disease, hepatic dysfunction, renal failure requiring dialysis, HIV infection, and melanoma skin cancer
  • no history of chemotherapy or radiotherapy in the previous 6 months
  • absence of severe psychiatric disease that limited comprehension
  • not taking any vitamin and/or mineral supplementation.

Exclusion Criteria:

  • subjects did not complete the entire course of supplemental therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vitamin E, C and Zinc

    Placebo

    Arm 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.

    Capsule containing only lactose

    Outcomes

    Primary Outcome Measures

    OXIDATIVE STRESS BIOMARKERS
    8-isoprostane, Thiobarbituric Acid Reactive Substances (TBARS), Nitrite, Total Antioxidant Capacity (TAC)
    INFLAMMATORY STATE
    IL-1, IL-6, IL-10, TNF alfa

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2014
    Last Updated
    September 24, 2014
    Sponsor
    University of Campinas, Brazil
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02248584
    Brief Title
    VITAMIN E, C and ZINC IN PATIENTS WITH SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE
    Official Title
    SUPPLEMENTATION OF VITAMIN E, C and ZINC IN PATIENTS WITH NON-MELANOMA SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campinas, Brazil

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Neoplasms

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin E, C and Zinc
    Arm Type
    Experimental
    Arm 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 Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Capsule containing only lactose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin C, E and Zinc
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    OXIDATIVE STRESS BIOMARKERS
    Description
    8-isoprostane, Thiobarbituric Acid Reactive Substances (TBARS), Nitrite, Total Antioxidant Capacity (TAC)
    Time Frame
    one day before the start of supplementation or placebo administration and at 60 days after intervention
    Title
    INFLAMMATORY STATE
    Description
    IL-1, IL-6, IL-10, TNF alfa
    Time Frame
    one day before the start of supplementation or placebo administration and at 60 days after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients who had non-melanoma skin cancer (squamous cell carcinoma or basal cell carcinoma) and who were treated with surgery age ≥20 years absence of comorbidities such as type 1 diabetes, severe heart disease, hepatic dysfunction, renal failure requiring dialysis, HIV infection, and melanoma skin cancer no history of chemotherapy or radiotherapy in the previous 6 months absence of severe psychiatric disease that limited comprehension not taking any vitamin and/or mineral supplementation. Exclusion Criteria: subjects did not complete the entire course of supplemental therapy.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26509174
    Citation
    Freitas Bde J, Lloret GR, Visacri MB, Tuan BT, Amaral LS, Baldini D, de Sousa VM, de Castro LL, Aguiar JR, Pincinato Ede C, Mazzola PG, Moriel P. High 15-F2t-Isoprostane Levels in Patients with a Previous History of Nonmelanoma Skin Cancer: The Effects of Supplementary Antioxidant Therapy. Biomed Res Int. 2015;2015:963569. doi: 10.1155/2015/963569. Epub 2015 Oct 5.
    Results Reference
    derived

    Learn more about this trial

    VITAMIN E, C and ZINC IN PATIENTS WITH SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE

    We'll reach out to this number within 24 hrs