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Trial Title:
Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection
NCT ID:
NCT06017661
Condition:
Immunomodulation
Conditions: Official terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Conditions: Keywords:
chokeberry
Nutridrink
immunomodulation
tumor resection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
Description:
2 times a day
Arm group label:
Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
Intervention type:
Dietary Supplement
Intervention name:
Nutridrink Skin Repair
Description:
2 times a day
Arm group label:
Nutridrink Skin Repair
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólne
Address:
City:
Gdańsk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Barbara Khaidakov, PhD
Phone:
798 210 651
Phone ext:
+48
Email:
barbara.khaidakov@aronpharma.pl
Investigator:
Last name:
Piotr Spychalski
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
December 15, 2023
Lead sponsor:
Agency:
AronPharma Sp. z o. o.
Agency class:
Industry
Source:
AronPharma Sp. z o. o.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06017661
