Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

June 4, 2018 updated by: Catalysis SL

"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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • La Habana
      • Vedado, La Habana, Cuba, 10400
        • National Institute of Oncology and Radiobiology of Cuba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oncoxin-Viusid®
Radiotherapy + Chemotherapy + 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
PLACEBO_COMPARATOR: Placebo
Radiotherapy + Chemotherapy + Placebo
Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and placebo (75ml/day) before/during/after both treatments

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the therapeutic range of radiotherapy
Time Frame: 4 months
Kaplan-Meyer's Method
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Ivonne Chon, Dr., INOR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2015

Primary Completion (ACTUAL)

October 16, 2017

Study Completion (ACTUAL)

October 30, 2017

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (ACTUAL)

May 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head Cancer Neck

Clinical Trials on Oncoxin-Viusid®

3
Subscribe