Skip to main content
OpenTrials
Completed

NCT Number: NCT03550482

Oncoxin® and Quality of Life in Cancer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Stage II Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Digestive System Diseases Digestive System Neoplasms Gastric Cancer Stage III Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage III Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kazakh Research Institute of Oncology and Radiology, Almaty, Kazakhstan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • R0 surgery
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Emotional Quality of life

    Time frame: 20 days

    emotional SDS ESAS domains

  2. Toxicity produced by Chemotherapy

    Time frame: 20 days

    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.

  3. Toxicity produced by Chemotherapy

    Time frame: 20 days

    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.

  4. Physical Quality of Life

    Time frame: 20 days

    Physical SDS ESAS scores

  5. Nutritional level

    Time frame: 20 days

    Serum albumin level measures

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

ONCOXIN® and Quality of Life in Cancer Patients in a Real World Setting Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.