Oncoxin® and Quality of Life in Cancer Patients

Catalysis SL

Status and phase: Completed; Phase 4

Conditions: Non-small Cell Lung Cancer Stage II; Gastric Cancer Stage II; Gastric Cancer Stage III; Non-small Cell Lung Cancer Stage III

Treatments: Dietary Supplement: ONCOXIN®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03550482

OOS-CANCER-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients who had signed an informed consent.
2. Males and females aged 50-70 y/o
3. Gastric cancer IIB-IIIC, Non-small cell lung cancer IIB-IIIA
4. R0 surgery
5. 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.
6. Body mass index (BMI) ≥ 15, serum albumin ≥ 25 g/l.
7. Eastern Cooperative Oncology Group performance status ≤ 2

Exclusion criteria

1. 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).
2. The patient's family or official relations with a member of staff of the study center.
3. The patient's failure to assess his/her physical and/or emotional condition.
4. The patient's failure to comply with the study requirements.
5. The patient's refusal to participate in the study and pregnancy or lactation.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

Oncoxin®

Experimental group

Treatment:

Dietary Supplement: ONCOXIN®

Control

No Intervention group