Oncoxin-Viusid with Radiotherapy and Chemotherapy in Patients with Head and Neck Cancer: Results from a Phase II, Randomised, Double-Blind Study

Abstract

Objective: Antioxidant supplements seem to reduce toxicity associated with radiotherapy (RT) and chemotherapy (CT) in patients with head and neck (H&N) cancers. Ocoxin-Viusid (OV) has recognized antioxidant, immunostimulant, and anti-tumor effects. Our study was aimed to evaluate the efficacy and safety of OV in patients with H&N tumors during treatment with RT and CT. Methods: A total of 60 patients with a diagnosis of H&N carcinoma and indication of radiotherapy concurrent with chemotherapy were included in a phase II, randomized, prospective, controlled, double-blind study with two treatment arms: RT+CT+Placebo (n=30) and RT+CT+OV (n=30) during one year at a tertiary referral academic center (National Institute of Oncology from Havana, Cuba) from January 2015 to January 2016, with the objective of evaluating RT-CT toxicity reduction and improving patient quality of life. Results: There was no significant difference between the two groups in regard to male predominance; median age of 60, histological diagnosis of squamous cell carcinoma of the oropharynx in locally-advanced stages. The experimental OV group obtained better results insofar as a lower number and duration of interruptions in RT and lower severity of RT-CT toxicity levels, with acceptable local tumor control and overall survival in accordance with the clinical stage of the disease. No adverse effects were recorded in relation to the OV supplement. Conclusion: Our results suggest that administration of ocoxin-viusid during radiotherapy and chemotherapy improves patient quality of life by decreasing the number and level of toxicities from these treatments without interfering with their mechanism of action.