ImmunomodulationNCT06017661
Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection
A study testing Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds and Nutridrink Skin Repair in people with Immunomodulation, run by AronPharma Sp. z o. o. at 1 site in Poland.
Trial summary
The aim of the study is to demonstrate, under clinical conditions, the effectiveness of the standard product 'Nutridrink' enriched with a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting the recovery of oncology patients undergoing surgical resection of tumours. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immunomodulation
- What is being tested?
- Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds and Nutridrink Skin Repair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2023to 15 Dec 2023
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men, 18-80 years old
- Patients diagnosed with resectable gastrointestinal tract cancer undergo the resection procedure no later than one month after being enrolled in the study
- Signed informed consent
Who cannot join
- Intake of supplements containing plant extracts, polyphenols or anthocyanins
- Participation in another clinical trial
- Inability to consume the investigational product in liquid form as medication/placebo
- Women who are pregnant, planning to become pregnant during the study or breastfeeding
- Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation
- Hypersensitivity/allergy to any of the ingredient
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólne
Gdansk, 80-214
Barbara Khaidakov, PhD, 798 210 651 ext. +48, barbara.khaidakov@aronpharma.pl
Piotr Spychalski
About this study
The aim of the study is to demonstrate, under clinical conditions, the effectiveness of the standard product 'Nutridrink' enriched with a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting the recovery of oncology patients undergoing surgical resection of tumours.
Read the detailed description
Oncology patients undergoing the procedure are exposed to various postoperative complications. Nutridrink with a mixture of extracts with anti-inflammatory and antioxidative properties aims to provide the patient with essential nutrients and bioactive substances that can reduce the inflammatory state, protect cells from oxidative damage, and decrease the risk of complications while supporting tissue healing processes after the surgical procedure. The study group are oncology patients undergoing surgical resection of gastrointestinal tumour. During the study, the effects of the mixture on levels of oxidative stress and inflammation markers will be assessed, as well as the subjective evaluation of patients' quality of life and well-being after surgical surgical tumor resection.
- Conditions
- Immunomodulation
- Being tested
- Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds, Nutridrink Skin Repair
- Keywords
- chokeberry, Nutridrink, immunomodulation, tumor resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compoundsDietary supplement
2 times a day
Nutridrink Skin RepairDietary supplement
2 times a day
| Study group | Role | What they receive |
|---|---|---|
| Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds | Experimental | Group of 15 patients undergoing surgical resection of tumour Receives: Dietary Supplement: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds |
| Nutridrink Skin Repair | Active comparator | Group of 15 patients undergoing surgical resection of tumour Receives: Dietary Supplement: Nutridrink Skin Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOD level
Comparison of SOD level
Measured: Baseline, 3 weeks, 6 weeks
GSH level
Comparison of GSH level
Measured: Baseline, 3 weeks, 6 weeks
IL-6 level
Comparison of IL-6 level
Measured: Baseline, 3 weeks, 6 weeks
IL-8 level
Comparison of IL-8 level
Measured: Baseline, 3 weeks, 6 weeks
Secondary outcomes (1)
Patients' quality of life
Subjective assessment of patients' quality of life after surgical resection of the tumor (questionnaire). Higher scores mean a better outcome.
Measured: Baseline, 3 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Sep 2023
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunomodulationStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AronPharma Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017661
- Sponsor's protocol ID
- 09-AP-ONCON
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection
- ClinicalTrials.gov ID
- NCT06017661
- Acronym / sponsor ID
- 09-AP-ONCON
- Conditions
- Immunomodulation
- Keywords
- chokeberry, Nutridrink, immunomodulation, tumor resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AronPharma Sp. z o. o.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 30 Aug 2023 (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.
The aim of the study is to demonstrate, under clinical conditions, the effectiveness of the standard product 'Nutridrink' enriched with a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting the recovery of oncology patients undergoing surgical resection of tumours.
Detailed description
Oncology patients undergoing the procedure are exposed to various postoperative complications. Nutridrink with a mixture of extracts with anti-inflammatory and antioxidative properties aims to provide the patient with essential nutrients and bioactive substances that can reduce the inflammatory state, protect cells from oxidative damage, and decrease the risk of complications while supporting tissue healing processes after the surgical procedure. The study group are oncology patients undergoing surgical resection of gastrointestinal tumour. During the study, the effects of the mixture on levels of oxidative stress and inflammation markers will be assessed, as well as the subjective evaluation of patients' quality of life and well-being after surgical surgical tumor resection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds | Experimental | Dietary Supplement: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compoundsGroup of 15 patients undergoing surgical resection of tumour |
| Nutridrink Skin Repair | Active comparator | Dietary Supplement: Nutridrink Skin RepairGroup of 15 patients undergoing surgical resection of tumour |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women and men, 18-80 years old
- Patients diagnosed with resectable gastrointestinal tract cancer undergo the resection procedure no later than one month after being enrolled in the study
- Signed informed consent
Key exclusion criteria (6 listed)
- Intake of supplements containing plant extracts, polyphenols or anthocyanins
- Participation in another clinical trial
- Inability to consume the investigational product in liquid form as medication/placebo
- Women who are pregnant, planning to become pregnant during the study or breastfeeding
- Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation
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 |
|---|---|---|
| Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds2 times a day | Dietary supplement | Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds |
| Nutridrink Skin Repair2 times a day | Dietary supplement | Nutridrink Skin Repair |
Primary outcome
SOD level
Time frame: Baseline, 3 weeks, 6 weeks
Comparison of SOD level
GSH level
Time frame: Baseline, 3 weeks, 6 weeks
Comparison of GSH level
IL-6 level
Time frame: Baseline, 3 weeks, 6 weeks
Comparison of IL-6 level
IL-8 level
Time frame: Baseline, 3 weeks, 6 weeks
Comparison of IL-8 level
1 secondary outcome
Patients' quality of life
Time frame: Baseline, 3 weeks, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólne
Gdansk, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds and Nutridrink Skin Repair in people with Immunomodulation, run by AronPharma Sp. z o. o. at 1 site in Poland.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOD level (time frame: Baseline, 3 weeks, 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2023.