Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

Phase 2

Completed

• Conditions: Head Cancer Neck
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Oncoxin-Viusid®

• Registration Number: NCT03541772
• Lead Sponsor: Catalysis SL

Brief Summary

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.

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.

Study Timeline

• Study Start: 2015-01-20
• Primary Completion: 2017-10-16
• Study Completion: 2017-10-30
• Study First Submitted: 2018-04-24
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-05-31
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Radiotherapy + Chemotherapy + Placebo
Oncoxin-Viusid®	Oncoxin-Viusid®	Radiotherapy + Chemotherapy + Oncoxin-viusid®

Primary Outcome Measures

Name	Time	Method
Improve the quality of life of patients during radiotherapy	4 months	Index of Karnofsky
Decrease the degrees of toxicities of Radiotherapy and Chemotherapy	4 months	physical examination

Secondary Outcome Measures

Name	Time	Method
Duration of the therapeutic range of radiotherapy	4 months	Kaplan-Meyer's Method

Trial Locations

Locations (1)

National Institute of Oncology and Radiobiology of Cuba; 🇨🇺 Vedado, La Habana, Cuba