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Oncoxin® and Quality of Life in Cancer Patients

Primary Purpose

Gastric Cancer Stage II, Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage III

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ONCOXIN®
Sponsored by
Catalysis SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer Stage II focused on measuring Oncoxin, Nutritional supplement, Chemotherapy, Oxidative stress, Antioxidant

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kazakh Research Institute of Oncology and Radiology
  • State Municipal Enterprise on the Right of Economic Management "Almaty Oncology Center" of Almaty Healthcare Administration
  • State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital
  • Medical Center "EVIMED" LLC
  • State-funded Healthcare Institution Oncologic Clinical Dispensary No.1
  • The Loginov Moscow Clinical Scientific Center, www.mknc.ru
  • Medical University "Reaviz"
  • Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk
  • State-funded Institution "Surgut Regional Hospital"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oncoxin®

Control

Arm Description

Outcomes

Primary Outcome Measures

Quality of life improvement
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 Outcome Measures

Emotional Quality of life
emotional SDS ESAS domains
Toxicity produced by Chemotherapy
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.
Toxicity produced by Chemotherapy
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.
Physical Quality of Life
Physical SDS ESAS scores
Nutritional level
Serum albumin level measures

Full Information

First Posted
May 25, 2018
Last Updated
June 3, 2019
Sponsor
Catalysis SL
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1. Study Identification

Unique Protocol Identification Number
NCT03550482
Brief Title
Oncoxin® and Quality of Life in Cancer Patients
Official Title
ONCOXIN® and Quality of Life in Cancer Patients in a Real World Setting Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer Stage II, Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage III, Gastric Cancer Stage III
Keywords
Oncoxin, Nutritional supplement, Chemotherapy, Oxidative stress, Antioxidant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Study multicenter open-label nonrandomized clinical trial in two parallel groups with a 20-day treatment period. No follow-up period was intended. Following visits were scheduled: Visit 1 - the first day of 2nd and further course of ACT before ACT drugs administration; Visit 2 - 7±1 days before next course of ACT; Visit 3 - the day of next course of ACT before ACT drugs administration (21±3 days after Visit 1). It is expected, that the proportion of patients with MCID improvement in total SDS ESAS was 50% in ONCX group and 20% in control group (with baseline total SDS ESAS of 30 points). Based on patients' allocation as 2:1 in comparison groups for the ONCX and control groups, respectively, alpha 0.05 and power not less than 0.9 data of 120 patients has to be analyzed. With the dropout of 25% 150 patients has to be included in the study (100 ONCX/50 controls).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oncoxin®
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
ONCOXIN®
Intervention Description
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 Outcome Measure Information:
Title
Quality of life improvement
Description
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)
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Emotional Quality of life
Description
emotional SDS ESAS domains
Time Frame
20 days
Title
Toxicity produced by Chemotherapy
Description
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.
Time Frame
20 days
Title
Toxicity produced by Chemotherapy
Description
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.
Time Frame
20 days
Title
Physical Quality of Life
Description
Physical SDS ESAS scores
Time Frame
20 days
Title
Nutritional level
Description
Serum albumin level measures
Time Frame
20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kazakh Research Institute of Oncology and Radiology
City
Almaty
Country
Kazakhstan
Facility Name
State Municipal Enterprise on the Right of Economic Management "Almaty Oncology Center" of Almaty Healthcare Administration
City
Almaty
Country
Kazakhstan
Facility Name
State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital
City
Ugra
State/Province
Tyumen Region
ZIP/Postal Code
628012
Country
Russian Federation
Facility Name
Medical Center "EVIMED" LLC
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
State-funded Healthcare Institution Oncologic Clinical Dispensary No.1
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
The Loginov Moscow Clinical Scientific Center, www.mknc.ru
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Medical University "Reaviz"
City
Samara
ZIP/Postal Code
443001
Country
Russian Federation
Facility Name
Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Facility Name
State-funded Institution "Surgut Regional Hospital"
City
Surgut
ZIP/Postal Code
628400
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31641390
Citation
Kaidarova DR, Kopp MV, Pokrovsky VS, Dzhugashvili M, Akimzhanova ZM, Abdrakhmanov RZ, Babich EN, Bilan EV, Byakhov AV, Gurov SN, Koroleva IA, Mochalova AS, Povaga SS, Raigorodsky MV, Saifullin AS, Sanz E, Petrovskiy FI. Multicomponent nutritional supplement Oncoxin and its influence on quality of life and therapy toxicity in patients receiving adjuvant chemotherapy. Oncol Lett. 2019 Nov;18(5):5644-5652. doi: 10.3892/ol.2019.10868. Epub 2019 Sep 13.
Results Reference
derived

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Oncoxin® and Quality of Life in Cancer Patients

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