Trials / Completed
CompletedNCT03550482
Oncoxin® and Quality of Life in Cancer Patients
ONCOXIN® and Quality of Life in Cancer Patients in a Real World Setting Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Catalysis SL · Industry
- Sex
- All
- Age
- 50 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Gastric Cancer Stage II
- Non-small Cell Lung Cancer Stage II
- Non-small Cell Lung Cancer Stage III
- Gastric Cancer Stage III
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | ONCOXIN® | 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. |
Timeline
- Start date
- 2017-11-01
- Primary completion
- 2019-03-15
- Completion
- 2019-05-15
- First posted
- 2018-06-08
- Last updated
- 2019-06-05
Locations
9 sites across 2 countries: Kazakhstan, Russia
Source: ClinicalTrials.gov record NCT03550482. Inclusion in this directory is not an endorsement.