Skip to main content
OpenTrials
Completed

NCT Number: NCT03541772

Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head Cancer Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Oncology and Radiobiology of Cuba

Vedado, La Habana, 10400, Cuba

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oncoxin-Viusid®

Dietary Supplement

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

Placebo

Dietary Supplement

Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and placebo (75ml/day) before/during/after both treatments

Primary outcomes

  1. Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    Time frame: 4 months

    Tumor biopsy

  2. Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    Time frame: 4 months

    Biochemical analysis of urine

  3. Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    Time frame: 4 months

    anamnesis

  4. Decrease the degrees of toxicities of Radiotherapy and Chemotherapy

    Time frame: 4 months

    physical examination

  5. Improve the quality of life of patients during radiotherapy

    Time frame: 4 months

    Index of Karnofsky

Secondary outcomes

  1. Duration of the therapeutic range of radiotherapy

    Time frame: 4 months

    Kaplan-Meyer's Method

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 31, 2018
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.