Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head Cancer Neck

Intervention / Treatment
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* Dietary Supplement: Oncoxin-Viusid®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oncoxin-Viusid®<br>Radiotherapy + Chemotherapy + Oncoxin-viusid® | Dietary Supplement: Oncoxin-Viusid®<br>* Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and Oncoxin-Viusid® (75 ml/day) before/during/after both treatments<br>|
| Placebo Comparator: Placebo<br>Radiotherapy + Chemotherapy + Placebo | Dietary Supplement: Placebo<br>* Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and placebo (75ml/day) before/during/after both treatments<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head Carcinoma, Neck Carcinoma, Chemotherapy, Radiotherapy, Oncoxin Viusid, Nutritional supplement