Gastric Cancer Stage IIPhase 4NCT03550482
Oncoxin® and Quality of Life in Cancer Patients
A Phase 4 study testing ONCOXIN® in people with Gastric Cancer Stage II and Non-small Cell Lung Cancer Stage II, run by Catalysis SL at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Gastric Cancer Stage II, Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage III
- What is being tested?
- ONCOXIN®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Nov 2017to 15 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Russia7 sites
Medical Center "EVIMED" LLC
Chelyabinsk, 454048
State-funded Healthcare Institution Oncologic Clinical Dispensary No.1
Moscow, 111123
The Loginov Moscow Clinical Scientific Center, www.mknc.ru
Moscow, 111123
Medical University "Reaviz"
Samara, 443001
Non-government Healthcare Institution " Hospital of JSC Russian Railways Hospital at the Station Smolensk
Smolensk, 214025
State-funded Institution "Surgut Regional Hospital"
Surgut, 628400
State-funded Institution of Khanty-Mansiysk Regional Clinical Hospital
Ugra, Tyumen Oblast, 628012
Kazakhstan2 sites
Kazakh Research Institute of Oncology and Radiology
Almaty
State Municipal Enterprise on the Right of Economic Management "Almaty Oncology Center" of Almaty Healthcare Administration
Almaty
About this study
Official title: ONCOXIN® and Quality of Life in Cancer Patients in a Real World Setting Study
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.
Read the 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.
- Conditions
- Gastric Cancer Stage II, Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage III, Gastric Cancer Stage III
- Being tested
- ONCOXIN®
- Keywords
- Oncoxin, Nutritional supplement, Chemotherapy, Oxidative stress, Antioxidant
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Oncoxin® | Experimental | Not described Receives: Dietary Supplement: ONCOXIN® |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 20 days
Secondary outcomes (5)
Emotional Quality of life
emotional SDS ESAS domains
Measured: 20 days
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.
Measured: 20 days
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.
Measured: 20 days
Physical Quality of Life
Physical SDS ESAS scores
Measured: 20 days
Nutritional level
Serum albumin level measures
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Nov 2017
- Primary completion15 Mar 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer Stage IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550482
- Sponsor's protocol ID
- OOS-CANCER-5
- Status last verified
- May 2018
- First submitted
- 25 May 2018
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31641390
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONCOXIN® and Quality of Life in Cancer Patients in a Real World Setting Study
- ClinicalTrials.gov ID
- NCT03550482
- Acronym / sponsor ID
- OOS-CANCER-5
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Oncoxin® | Experimental | Dietary Supplement: ONCOXIN® |
| Control | No intervention | – |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Oncoxin® |
Primary outcome
Quality of life improvement
Time frame: 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)
5 secondary outcomes
Emotional Quality of life
Time frame: 20 days
Toxicity produced by Chemotherapy
Time frame: 20 days
Toxicity produced by Chemotherapy
Time frame: 20 days
Physical Quality of Life
Time frame: 20 days
Nutritional level
Time frame: 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 31641390Kaidarova 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ONCOXIN® in people with Gastric Cancer Stage II and Non-small Cell Lung Cancer Stage II, run by Catalysis SL at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life improvement (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03550482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.