Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

Catalysis SL

Status and phase: Completed; Phase 2

Conditions: Head Cancer Neck

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Oncoxin-Viusid®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03541772

OOS-CANCER-1

Details and patient eligibility

About

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 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Oncoxin-Viusid®

Experimental group

Description:

Radiotherapy + Chemotherapy + Oncoxin-viusid®

Treatment:

Dietary Supplement: Oncoxin-Viusid®

Placebo

Placebo Comparator group

Description:

Radiotherapy + Chemotherapy + Placebo

Treatment:

Dietary Supplement: Placebo