Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

"Combined Oncoxin-Viusid® Treatment With Radiotherapy and Chemotherapy in Patients With Head and Neck Cancer. Phase II, Randomized and Double-blind Study"

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.

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.

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.