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Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541772
Recruitment Status : Completed
First Posted : May 31, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head Cancer Neck Dietary Supplement: Oncoxin-Viusid® Dietary Supplement: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: "Combined Oncoxin-Viusid® Treatment With Radiotherapy and Chemotherapy in Patients With Head and Neck Cancer. Phase II, Randomized and Double-blind Study"
Actual Study Start Date : January 20, 2015
Actual Primary Completion Date : October 16, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Oncoxin-Viusid®
Radiotherapy + Chemotherapy + Oncoxin-viusid®
 Dietary Supplement: 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
 Dietary Supplement: Placebo
Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and placebo (75ml/day) before/during/after both treatments


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Duration of the therapeutic range of radiotherapy [ Time Frame: 4 months ]
    Kaplan-Meyer's Method


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541772


Locations
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Cuba
National Institute of Oncology and Radiobiology of Cuba
Vedado, La Habana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
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Principal Investigator: Ivonne Chon, Dr. INOR
More Information
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Publications:

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Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03541772    
Other Study ID Numbers: OOS-CANCER-1
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catalysis SL:
Head Carcinoma
Neck Carcinoma
Chemotherapy
 Radiotherapy
Oncoxin Viusid
Nutritional supplement
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms