Efficacy of Oncoxin-Viusid on the Reduction of Adverse Reactions to Chemotherapy and Radiotherapy in Patients Diagnosed with Cervical Cancer and Endometrial Adenocarcinoma
What this study found
Oncoxin-Viusid reduced the occurrence of adverse reactions from chemotherapy by 20.6% compared to the placebo group, improved several quality of life indicators significantly, and allowed patients to tolerate more doses of chemotherapy.
- Study & population
- 63 female patients, age range 33 to 81 years, receiving standard treatment with either Oncoxin-Viusid or placebo, assessing adverse reactions and quality of life parameters.
- Intervention
- A controlled, randomised double-blind phase II clinical trial involving 63 patients with locally advanced cervical cancer and endometrial adenocarcinoma to assess the efficacy of Oncoxin-Viusid in reducing adverse reactions from chemotherapy and radiotherapy.
- Key limitation
- Differences in histological diagnosis between groups might influence the severity of adverse events and treatment responses.
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Open PDFOriginal abstract
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.