It is expected that additional support with certain micronutrients may improve prognosis, decrease the frequency of side effects and complications and maintain high relative dose intensity of anticancer treatments. Food supplement ONCOXIN (ONCX) contains amino acids, vitamins, minerals and biologically active substances of natural origin with high immunostimulatory and antioxidant activity. Present study is a real world experience study intended to evaluate the efficacy of ONCX in cancer patients.
The study was conducted at 9 centers across the Russia and Kazakhstan. Patients were allocated in 2:1 comparison groups for the ONCX and control groups, respectively. A total of 133 patients were enrolled in the study; 84 in the ONCX group and 49 as controls. ONCX contains microelements, vitamins, amino acids and certain naturally occurring, biologically active substances. It is expected that additional support with certain micronutrients may improve prognosis, decrease the frequency of side effects and complications and maintain the Quality of life in cancer patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
133
Adjuvant chemotherapy regimen (XELOX or paclitaxel+carboplatin) + Oncoxin 25 ml twice daily for 20 days. In case of nausea/vomiting after ONCX use patients were advised to dilute it in water, juice or milk. Patients with BMI \<20 and serum albumin levels \<30 g/l received nutritional support.
Kazakh Research Institute of Oncology and Radiology
Almaty, Kazakhstan
State Municipal Enterprise on the Right of Economic Management "Almaty Oncology Center" of Almaty Healthcare Administration
Almaty, Kazakhstan
State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital
Ugra, Tyumen Oblast, Russia
Medical Center "EVIMED" LLC
Chelyabinsk, Russia
State-funded Healthcare Institution Oncologic Clinical Dispensary No.1
Moscow, Russia
The Loginov Moscow Clinical Scientific Center, www.mknc.ru
Moscow, Russia
Medical University "Reaviz"
Samara, Russia
Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk
Smolensk, Russia
State-funded Institution "Surgut Regional Hospital"
Surgut, Russia
Quality of life improvement
The proportion of patients who had an improvement in the QoL corresponding to the minimal clinically important difference (MCID) that any patient was able to feel at Visits 2 in total SDS ESAS (6 points within patient change for improvement)
Time frame: 20 days
Emotional Quality of life
emotional SDS ESAS domains
Time frame: 20 days
Toxicity produced by Chemotherapy
Common toxicity criteria NCI-CTC. Common Terminology Criteria for Adverse Events (AE) is a descriptive terminology which can be utilized for Adverse Event reporting. A grading (severity) scale is provided for each AE term.
Time frame: 20 days
Toxicity produced by Chemotherapy
Body Mass Index (BMI) combined with albumin. High body mass index (BMI) has been inconsistently associated with overall survival. Preoperative body mass index, blood albumin and triglycerides predict survival for patients with gastric cancer.
Time frame: 20 days
Physical Quality of Life
Physical SDS ESAS scores
Time frame: 20 days
Nutritional level
Serum albumin level measures
Time frame: 20 days
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