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

Not Applicable

Completed

• Conditions: Skin Neoplasms
• Interventions: Dietary Supplement: Vitamin C, E and Zinc

• Registration Number: NCT02248584
• Lead Sponsor: University of Campinas, Brazil

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-24
• Last Update Submitted: 2014-09-24
• Study First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin E, C and Zinc	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.

Primary Outcome Measures

Name	Time	Method
OXIDATIVE STRESS BIOMARKERS	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	one day before the start of supplementation or placebo administration and at 60 days after intervention	IL-1, IL-6, IL-10, TNF alfa