Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

Overview

Nutritional supplements containing antioxidants seem to decrease toxicity associated with Radiotherapy (RT) and Chemotherapy (CT) in patients with malignant head and neck tumors. Oncoxin-Viusid® (OV) is a nutritional supplement with antioxidant, immunomodulator and antitumor effects.

Full Title of Study: “”Combined Oncoxin-Viusid® Treatment With Radiotherapy and Chemotherapy in Patients With Head and Neck Cancer. Phase II, Randomized and Double-blind Study””

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 16, 2017

Detailed Description

Objective To assess the efficacy and safety of OV in patients with head and neck tumors during treatment with radio-chemotherapy. Materials and Methods Patients diagnosed with Head and Neck Carcinoma, and indicated to follow a radiotherapy treatment concurrent with Radiosensitizing Chemotherapy, were included in a phase II, randomized, prospective, controlled and double-blind study in two treatment arms: RT + CT + Placebo (n = 30) and RT + CT + OV (n = 30) during one year in a tertiary center (INOR), with the aim of evaluating the reduction of toxicities of RT-CT and improve the quality of life of patients during these oncospecific treatments.

Interventions

  • Dietary Supplement: Oncoxin-Viusid®
    • Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and Oncoxin-Viusid® (75 ml/day) before/during/after both treatments
  • Dietary Supplement: Placebo
    • Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and placebo (75ml/day) before/during/after both treatments

Arms, Groups and Cohorts

  • Experimental: Oncoxin-Viusid®
    • Radiotherapy + Chemotherapy + Oncoxin-viusid®
  • Placebo Comparator: Placebo
    • Radiotherapy + Chemotherapy + Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
    • Time Frame: 4 months
    • Tumor biopsy
  • Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
    • Time Frame: 4 months
    • Biochemical analysis of urine
  • Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
    • Time Frame: 4 months
    • anamnesis
  • Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
    • Time Frame: 4 months
    • physical examination
  • Improve the quality of life of patients during radiotherapy
    • Time Frame: 4 months
    • Index of Karnofsky

Secondary Measures

  • Duration of the therapeutic range of radiotherapy
    • Time Frame: 4 months
    • Kaplan-Meyer’s Method

Participating in This Clinical Trial

Inclusion Criteria

  • Patients of both sexes – over 18 years of age – With histological diagnosis of carcinoma of the head and neck – Regardless of the variety or degree of histological differentiation and clinical stage – Tributaries of concomitant treatment with ionizing radiation and radiosensitizing chemotherapy with intercurrent diseases compensated and index of Karnofsky > 59 – Acceptable hematological parameters – Women not pregnant or lactating – Who authorized their inclusion in the investigation, through their informed consent. Exclusion Criteria:

  • Patients with a second concomitant primary tumor and / or contraindication to platinum chemotherapy – Patients who are under another research protocol or who have decompensated psychiatric disorders.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Catalysis SL
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ivonne Chon, Dr., Principal Investigator, INOR

References

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Brizel DM, Wasserman TH, Henke M, Strnad V, Rudat V, Monnier A, Eschwege F, Zhang J, Russell L, Oster W, Sauer R. Phase III randomized trial of amifostine as a radioprotector in head and neck cancer. J Clin Oncol. 2000 Oct 1;18(19):3339-45. doi: 10.1200/JCO.2000.18.19.3339. Erratum In: J Clin Oncol 2000 Dec 15;18(24):4110-1.

Antonadou D, Pepelassi M, Synodinou M, Puglisi M, Throuvalas N. Prophylactic use of amifostine to prevent radiochemotherapy-induced mucositis and xerostomia in head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):739-47. doi: 10.1016/s0360-3016(01)02683-9.

Bardia A, Tleyjeh IM, Cerhan JR, Sood AK, Limburg PJ, Erwin PJ, Montori VM. Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis. Mayo Clin Proc. 2008 Jan;83(1):23-34. doi: 10.4065/83.1.23.

Lamson DW, Brignall MS. Natural agents in the prevention of cancer, part two: preclinical data and chemoprevention for common cancers. Altern Med Rev. 2001 Apr;6(2):167-87.

Marquez J, Mena J, Hernandez-Unzueta I, Benedicto A, Sanz E, Arteta B, Olaso E. Ocoxin(R) oral solution slows down tumor growth in an experimental model of colorectal cancer metastasis to the liver in Balb/c mice. Oncol Rep. 2016 Mar;35(3):1265-72. doi: 10.3892/or.2015.4486. Epub 2015 Dec 16.

Rodrigues MJ, Bouyon A, Alexandre J. [Role of antioxidant complements and supplements in oncology in addition to an equilibrate regimen: a systematic review]. Bull Cancer. 2009 Jun;96(6):677-84. doi: 10.1684/bdc.2009.0886. French.

Lamson DW, Brignall MS. Antioxidants in cancer therapy; their actions and interactions with oncologic therapies. Altern Med Rev. 1999 Oct;4(5):304-29.

Lamson DW, Brignall MS. Antioxidants and cancer therapy II: quick reference guide. Altern Med Rev. 2000 Apr;5(2):152-63.

Mahdavi R, Faramarzi E, Seyedrezazadeh E, Mohammad-Zadeh M, Pourmoghaddam M. Evaluation of oxidative stress, antioxidant status and serum vitamin C levels in cancer patients. Biol Trace Elem Res. 2009 Jul;130(1):1-6. doi: 10.1007/s12011-008-8309-2. Epub 2009 Jan 17.

Hernandez-Unzueta I, Benedicto A, Olaso E, Sanz E, Viera C, Arteta B, Marquez J. Ocoxin oral solution(R) as a complement to irinotecan chemotherapy in the metastatic progression of colorectal cancer to the liver. Oncol Lett. 2017 Jun;13(6):4002-4012. doi: 10.3892/ol.2017.6016. Epub 2017 Apr 10.

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