Head Cancer Neck
Conditions
Keywords
Head Carcinoma, Neck Carcinoma, Chemotherapy, Radiotherapy, Oncoxin Viusid, Nutritional supplement
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.
Interventions
DIETARY_SUPPLEMENTOncoxin-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
DIETARY_SUPPLEMENTPlacebo
Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and placebo (75ml/day) before/during/after both treatments
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease the degrees of toxicities of Radiotherapy and Chemotherapy | 4 months | Tumor biopsy |
| Improve the quality of life of patients during radiotherapy | 4 months | Index of Karnofsky |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the therapeutic range of radiotherapy | 4 months | Kaplan-Meyer's Method |
Countries
Cuba
Outcome results
None listed