Oncoxin® and Quality of Life in Cancer Patients

Phase 4

Completed

• Conditions: Non-small Cell Lung Cancer Stage II; Non-small Cell Lung Cancer Stage III; Gastric Cancer Stage II; Gastric Cancer Stage III
• Interventions: Dietary Supplement: ONCOXIN®

• Registration Number: NCT03550482
• Lead Sponsor: Catalysis SL

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 Timeline

• Study Start: 2017-11-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-08
• Primary Completion: 2019-03-15
• Study Completion: 2019-05-15
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oncoxin®	ONCOXIN®	-

Primary Outcome Measures

Name	Time	Method
Quality of life improvement	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 Outcome Measures

Name	Time	Method
Emotional Quality of life	20 days	emotional SDS ESAS domains
Toxicity produced by Chemotherapy	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.
Physical Quality of Life	20 days	Physical SDS ESAS scores
Nutritional level	20 days	Serum albumin level measures

Trial Locations

Locations (9)

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; 🇰🇿 Almaty, Kazakhstan

State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital; 🇷🇺 Ugra, Tyumen Region, Russian Federation

State-funded Healthcare Institution Oncologic Clinical Dispensary No.1; 🇷🇺 Moscow, Russian Federation

The Loginov Moscow Clinical Scientific Center, www.mknc.ru; 🇷🇺 Moscow, Russian Federation

Medical University "Reaviz"; 🇷🇺 Samara, Russian Federation

Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk; 🇷🇺 Smolensk, Russian Federation

State-funded Institution "Surgut Regional Hospital"; 🇷🇺 Surgut, Russian Federation

Medical Center "EVIMED" LLC; 🇷🇺 Chelyabinsk, Russian Federation