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
About this trial
This is an interventional prevention trial for Skin Neoplasms
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.
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
NCT ID
NCT02248584
First Posted
September 22, 2014
Last Updated
September 24, 2014
Sponsor
University of Campinas, Brazil
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
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VITAMIN E, C and ZINC IN PATIENTS WITH SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE
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