Oncoxin® and Quality of Life in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-05-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Oncoxin®

Group Type EXPERIMENTAL

ONCOXIN®

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No