Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncoxin® | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONCOXIN® | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Emotional Quality of life | emotional SDS ESAS domains | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31641390 | Derived | Kaidarova DR, Kopp MV, Pokrovsky VS, Dzhugashvili M, Akimzhanova ZM, Abdrakhmanov RZ, Babich EN, Bilan EV, Byakhov AV, Gurov SN, Koroleva IA, Mochalova AS, Povaga SS, Raigorodsky MV, Saifullin AS, Sanz E, Petrovskiy FI. Multicomponent nutritional supplement Oncoxin and its influence on quality of life and therapy toxicity in patients receiving adjuvant chemotherapy. Oncol Lett. 2019 Nov;18(5):5644-5652. doi: 10.3892/ol.2019.10868. Epub 2019 Sep 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Study multicenter open-label nonrandomized clinical trial in two parallel groups with a 20-day treatment period. No follow-up period was intended. Following visits were scheduled: Visit 1 - the first day of 2nd and further course of ACT before ACT drugs administration; Visit 2 - 7±1 days before next course of ACT; Visit 3 - the day of next course of ACT before ACT drugs administration (21±3 days after Visit 1).
It is expected, that the proportion of patients with MCID improvement in total SDS ESAS was 50% in ONCX group and 20% in control group (with baseline total SDS ESAS of 30 points). Based on patients' allocation as 2:1 in comparison groups for the ONCX and control groups, respectively, alpha 0.05 and power not less than 0.9 data of 120 patients has to be analyzed. With the dropout of 25% 150 patients has to be included in the study (100 ONCX/50 controls).
Not provided
Not provided
Not provided
Not provided
|
| 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. | 20 days |
| Physical Quality of Life | Physical SDS ESAS scores | 20 days |
| Nutritional level | Serum albumin level measures | 20 days |
| Almaty |
| Kazakhstan |
| State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital | Ugra | Tyumen Oblast | 628012 | Russia |
| Medical Center "EVIMED" LLC | Chelyabinsk | 454048 | Russia |
| State-funded Healthcare Institution Oncologic Clinical Dispensary No.1 | Moscow | 111123 | Russia |
| The Loginov Moscow Clinical Scientific Center, www.mknc.ru | Moscow | 111123 | Russia |
| Medical University "Reaviz" | Samara | 443001 | Russia |
| Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk | Smolensk | 214025 | Russia |
| State-funded Institution "Surgut Regional Hospital" | Surgut | 628400 | Russia |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |