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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02248584

Recruitment Status : Completed

First Posted : September 25, 2014

Last Update Posted : September 25, 2014

Sponsor:

Information provided by (Responsible Party):

Patricia Moriel, University of Campinas, Brazil

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.

Condition or disease	Intervention/treatment	Phase
Skin Neoplasms	Dietary Supplement: Vitamin C, E and Zinc	Not Applicable

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
Official Title:	SUPPLEMENTATION OF VITAMIN E, C and ZINC IN PATIENTS WITH NON-MELANOMA SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE
Study Start Date :	January 2011
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer Vitamin C Vitamin E

Drug Information available for: Ascorbic acid alpha-Tocopherol Sodium ascorbate Vitamin E Tocopherol alpha-Tocopherol succinate Zinc, elemental Tocopherol acetate DL-alpha-Tocopherol Magnesium ascorbate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vitamin E, C and Zinc 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.	Dietary Supplement: Vitamin C, E and Zinc 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.
Placebo Comparator: Placebo Capsule containing only lactose

Outcome Measures

Primary Outcome Measures :

OXIDATIVE STRESS BIOMARKERS [ Time Frame: one day before the start of supplementation or placebo administration and at 60 days after intervention ]
8-isoprostane, Thiobarbituric Acid Reactive Substances (TBARS), Nitrite, Total Antioxidant Capacity (TAC)
INFLAMMATORY STATE [ Time Frame: one day before the start of supplementation or placebo administration and at 60 days after intervention ]
IL-1, IL-6, IL-10, TNF alfa

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	20 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	Patricia Moriel, PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier:	NCT02248584
Other Study ID Numbers:	Betania
First Posted:	September 25, 2014 Key Record Dates
Last Update Posted:	September 25, 2014
Last Verified:	September 2014

Additional relevant MeSH terms:

Layout table for MeSH terms

Skin Neoplasms Neoplasms by Site Neoplasms Skin Diseases Ascorbic Acid Vitamins Micronutrients	Nutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents

To Top