RÉSUMÉ
The aim of the present study was to identify the efficacy and safety of Oncoxin-Viusid (OV) as a supportive treatment for patients with prostate cancer (PCA). A prospective, non-randomised, open-label phase II clinical trial, including 25 patients with hormone-refractory PCA (HRPC) was conducted at the Hospital Universitario General Calixto García (Havana, Cuba) between June 2017 and March 2018. Each of the patients received chemotherapy (CTX) and/or radiotherapy (RT) and OV treatment. Patients had a mean age of 73 years, clinical stage IV cancer and a high risk of relapse. Six cycles of CTX were completed by 80% of the patients, adverse reactions decreased and no weight loss was observed. Among the 25 patients, 5 were lost to follow-up and 4 died of disease progression. A total of 16 of these patients survived, of which 15 had an improved quality of life and 10 responded to treatment, with a significant reduction in pain and prostate symptoms and ≥50% reduction in baseline PSA. The progression-free survival (PFS) rate was 59% and the overall survival (OS) rate 64% at 1 year after treatment began. The OV nutritional supplement was effective, leading to a significant improvement in the patients' quality of life, good nutritional status and greater treatment tolerance. A clinical and humoral response was observed, with high survival rates and a delayed appearance of signs of disease progression. The present study was registered in ClinicalTrials.gov PRS with ID #NCT03543670.
RÉSUMÉ
Treatment of cancer often requires the use of adjuvant chemotherapy (ACT). In real clinical practice, numerous patients suffer from severe toxicity and reduced quality of life (QoL). Hence, there is a need to maintain QoL and to reduce therapy toxicity to comply with recommended chemotherapy (CT) regimens. The present study focused on the effects of the multi-component nutritional supplement Oncoxin (ONCX) on QoL and CT-induced toxicity in patients undergoing ACT. A total of 133 patients aged 50-70 years with gastric cancer IIB-IIIC or non-small cell lung cancer IIB-IIIA were enrolled in the present study: 84 received ONCX, and 49 were included in the control arm and received CT only. It was identified that after 2 weeks of treatment the patients receiving ONCX exhibited clinically meaningful improvement of QoL (measured by Edmonton Symptom Assessment System Questionnaire) compared with those in the control group (odds ratio, 2.07; 95% CI, 1.00-4.29). By the end of a 3 week-period, the albumin level was higher in patients of the ONCX group compared with those in the control group (mean, 38.1; 95% CI, 37.1-39.1 g/l; vs. mean, 35.5; 95% CI, 33.9-37.0; P=0.03; respectively). Furthermore, the use of ONCX substantively reduced the hepatic toxicity of ACT. The present prospective real clinical setting study revealed positive effects of ONCX on QoL and ACT toxicity. The present study was retrospectively registered under the study registration number NCT03550482 at ClinicalTrials.gov (June 8, 2018).
RÉSUMÉ
Oral mucositis (OM) is a common and potentially dangerous complication of anticancer treatment. Since there are only few therapeutic options for OM, there is a need to identify novel approaches to its management and prevention. The aim of the present study was to evaluate the efficacy of Oncoxin (ONCX), a nutritional supplement that contains microelements, vitamins, amino acids and certain biologically active substances of natural origin, in cancer patients who receive chemotherapy, radiotherapy or a combination of the two. A total of 15 male and female patients (aged 45-75 years) with malignant neoplasms, who had been prescribed radiotherapy, chemotherapy or a combination of the two, with an Eastern Cooperative Oncology Group performance status score ≤3, and grade 2-3 OM based on the World Health Organization (WHO) Oral Toxicity Scale, were enrolled in a 20-day study; 10 patients were in the ONCX group and 5 served as controls. The patients were allowed to use any anticancer treatment and any type of OM care. In addition to their current treatment, patients in the ONCX group used 25 ml of the ONCX nutritional supplement twice daily for 20 days. The mean WHO Oral Toxicity Scale grade decreased by 41% in the ONCX group after ~7 days from the beginning of the study compared with minimal change in the control group. At the end of the study, the difference was even more prominent, with a 73 and 20% decrease from baseline in the ONCX and control groups, respectively (P<0.001). During the entire trial period, patients in the ONCX group were able to eat normally during 65% of the time, in contrast to only 29% in the control group (P=0.04). There were no statistically significant changes in absolute body mass, or in the number of days with normal appetite. This was a pilot study aiming to show the benefits of the ONCX nutritional supplement in OM, and the results demonstrated that ONCX rapidly improved the symptoms of OM and helped to maintain normal eating habits in patients undergoing cancer treatment.