"Combined Oncoxin-Viusid® Treatment With Radiotherapy and Chemotherapy in Patients With Head and Neck Cancer. Phase II, Randomized and Double-blind Study"
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Catalysis SL
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Oncoxin-Viusid®
Radiotherapy + Chemotherapy + Oncoxin-viusid®
Intervention: Oncoxin-Viusid® (Dietary Supplement)
Placebo
Radiotherapy + Chemotherapy + Placebo
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
Time Frame: 4 months
Tumor biopsy
Improve the quality of life of patients during radiotherapy
Time Frame: 4 months
Index of Karnofsky
Secondary Outcomes
- Duration of the therapeutic range of radiotherapy(4 months)