Oncoxin® and Quality of Life in Cancer Patients

NCT03550482 | Completed Phase 4 DMC

• 1 other identifier: OOS-CANCER-5
• Study Type: interventional
• Target: 133
• Locations: 2 countries
• Sites: 9

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

  20 days

Secondary Outcomes (5)

• Emotional Quality of life

  20 days

• Toxicity produced by Chemotherapy

  20 days

• Toxicity produced by Chemotherapy

  20 days

• Physical Quality of Life

  20 days

• Nutritional level

  20 days

Study Arms (2)

Oncoxin®

EXPERIMENTAL

Dietary Supplement: ONCOXIN®

Control

NO INTERVENTION

Interventions

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.

Oncoxin®

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (9)

Kazakh Research Institute of Oncology and Radiology

Almaty, Kazakhstan

Location

State Municipal Enterprise on the Right of Economic Management "Almaty Oncology Center" of Almaty Healthcare Administration

Almaty, Kazakhstan

Location

State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital

Ugra, Tyumen Oblast, 628012, Russia

Location

Medical Center "EVIMED" LLC

Chelyabinsk, 454048, Russia

Location

State-funded Healthcare Institution Oncologic Clinical Dispensary No.1

Moscow, 111123, Russia

Location

The Loginov Moscow Clinical Scientific Center, www.mknc.ru

Moscow, 111123, Russia

Location

Medical University "Reaviz"

Samara, 443001, Russia

Location

Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk

Smolensk, 214025, Russia

Location

State-funded Institution "Surgut Regional Hospital"

Surgut, 628400, Russia

Location

Related Publications (1)

• 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.

  PMID: 31641390 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: November 1, 2017
• Primary Completion: March 15, 2019
• Study Completion: May 15, 2019
• Last Updated: June 5, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

RU (7); KA (2)