Oncoxin® and Quality of Life in Cancer Patients

June 3, 2019 updated by: Catalysis SL

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan
        • 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
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454048
        • Medical Center "EVIMED" LLC
      • Moscow, Russian Federation, 111123
        • State-funded Healthcare Institution Oncologic Clinical Dispensary No.1
      • Moscow, Russian Federation, 111123
        • The Loginov Moscow Clinical Scientific Center, www.mknc.ru
      • Samara, Russian Federation, 443001
        • Medical University "Reaviz"
      • Smolensk, Russian Federation, 214025
        • Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk
      • Surgut, Russian Federation, 628400
        • State-funded Institution "Surgut Regional Hospital"
    • Tyumen Region
      • Ugra, Tyumen Region, Russian Federation, 628012
        • State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Oncoxin®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Quality of life
Time Frame: 20 days
emotional SDS ESAS domains
20 days
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.
20 days
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.
20 days
Physical Quality of Life
Time Frame: 20 days
Physical SDS ESAS scores
20 days
Nutritional level
Time Frame: 20 days
Serum albumin level measures
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

March 15, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OOS-CANCER-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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