Clinical trial NCT03550482: 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
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 133
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life improvement
timeFrame: 20 days
Secondary outcomes:
measure: Emotional Quality of life
timeFrame: 20 days
measure: Toxicity produced by Chemotherapy
timeFrame: 20 days
measure: Toxicity produced by Chemotherapy
timeFrame: 20 days
measure: Physical Quality of Life
timeFrame: 20 days
measure: Nutritional level
timeFrame: 20 days
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh Research Institute of Oncology and Radiology
city: Almaty
country: Kazakhstan
facility: State Municipal Enterprise on the Right of Economic Management "Almaty Oncology Center" of Almaty Healthcare Administration
city: Ugra
country: Russian Federation
facility: State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital
state: Tyumen Region
city: Chelyabinsk
country: Russian Federation
facility: Medical Center "EVIMED" LLC
city: Moscow
country: Russian Federation
facility: State-funded Healthcare Institution Oncologic Clinical Dispensary No.1
city: Moscow
country: Russian Federation
facility: The Loginov Moscow Clinical Scientific Center, www.mknc.ru
city: Samara
country: Russian Federation
facility: Medical University "Reaviz"
city: Smolensk
country: Russian Federation
facility: Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk
city: Surgut
country: Russian Federation
facility: State-funded Institution "Surgut Regional Hospital"
Study officials:
References:
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.