Efficacy of Oncoxin-Viusid on the Reduction of Adverse Reactions to Chemotherapy and Radiotherapy in Patients Diagnosed with Cervical Cancer and Endometrial Adenocarcinoma

Introduction: Oncoxin-Viusid (OV) has shown antioxidant, immunomodulatory and anti-tumour capabilities in experimental studies on humans and animal subjects. Acute toxicity of Radiation Therapy (RT) and Chemotherapy (CT) in patients with cervical cancer and endometrial adenocarcinoma impact quality of life and, therefore, outcomes of these therapies. Objective: To identify Oncoxin-Viusid’s efficacy in reducing acute toxicity produced by onco-specific treatments in patients with cervical cancer and endometrial adenocarcinoma. Materials and Methods: A controlled, randomised double-blind phase II clinical trial was performed with a sample size of 63 patients distributed into 2 groups: one receiving the standard treatment plus the Oncoxin-Viusid nutritional supplement (OV group) and another receiving the standard treatment and placebo (P group). The primary efficacy variable is the proportion of secondary disruptions to acute adverse reactions produced by RT and CT. Results: The number of patients suffering adverse events from chemotherapy was 20.6% less in the OV group (70.0%) than in the placebo group (90.6%) (p = 0.04). We recorded consistently normal values of haemoglobin (-6.2 OV group vs -8.3 P group, p = 0.009), platelet count (-17.4 OV group vs -27.6 P group, p = 0.009) and leukocytes (-31.8 OV group vs -41.4 P group, p = 0.025) in the OV group, tolerating 4 more cytostatic doses on average than the placebo group. Significant increase in quality of life (QLQ-30) was registered in the OV group with a large effect size on such issues as emotional and social function (Cohen’s d = 0.9), as well as in the reduction of symptoms like dyspnea 60%, insomnia 15% and anorexia 30% (item CX-2), (Cohen’s d = 0.98), which were higher than the placebo group. Conclusions: OV administration reduces onco-specific adverse events and improves quality of life in patients diagnosed with cervical cancer and endometrial adenocarcinoma undergoing radiation therapy and chemotherapy.