ONCOXIN® and Quality of Life in Cancer Patients in a Real World Setting Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Catalysis SL
- Enrollment
- 133
- Locations
- 16
- Primary Endpoint
- Quality of life improvement
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients who had signed an informed consent.
- •Males and females aged 50-70 y/o
- •Gastric cancer IIB-IIIC, Non-small cell lung cancer IIB-IIIA
- •Adjuvant chemotherapy (ACT) required, 2nd and further course of ACT, XELOX regimen of ACT for gastric cancer and paclitaxel+carboplatin regimen for non-small cell lung cancer.
- •Body mass index (BMI) ≥ 15, serum albumin ≥ 25 g/l.
- •Eastern Cooperative Oncology Group performance status ≤ 2
Exclusion Criteria
- •Severe concomitant diseases or conditions that may complicate or make impossible the patient's participation in the study, or make it difficult to interpret the clinical data (including mental disorders, severe infectious and parasitic diseases and intolerability to any of the ONCX components).
- •The patient's family or official relations with a member of staff of the study center.
- •The patient's failure to assess his/her physical and/or emotional condition.
- •The patient's failure to comply with the study requirements.
- •The patient's refusal to participate in the study and pregnancy or lactation.
Arms & Interventions
Oncoxin®
Intervention: ONCOXIN® (Dietary Supplement)
Control
Outcomes
Primary Outcomes
Quality of life improvement
Time Frame: 20 days
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)
Secondary Outcomes
- Emotional Quality of life(20 days)
- Physical Quality of Life(20 days)
- Nutritional level(20 days)
- Toxicity produced by Chemotherapy(20 days)