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

NCT02248584 | Completed

• 1 other identifier: Betania
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Neoplasms

Outcome Measures

Primary Outcomes (2)

• OXIDATIVE STRESS BIOMARKERS

  8-isoprostane, Thiobarbituric Acid Reactive Substances (TBARS), Nitrite, Total Antioxidant Capacity (TAC)

  one day before the start of supplementation or placebo administration and at 60 days after intervention

• INFLAMMATORY STATE

  IL-1, IL-6, IL-10, TNF alfa

  one day before the start of supplementation or placebo administration and at 60 days after intervention

Study Arms (2)

Vitamin E, C and Zinc

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Capsule containing only lactose

Interventions

Vitamin C, E and Zinc DIETARY_SUPPLEMENT

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.

Vitamin E, C and Zinc

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Related Publications (1)

• 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.

  PMID: 26509174 DERIVED

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Ascorbic Acid; Zinc

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 25, 2014

Record last verified: 2014-09