Back to resultsInvestigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection
Primary Purpose
Immunomodulation
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
Nutridrink Skin Repair
Sponsored by
About this trial
This is an interventional supportive care trial for Immunomodulation focused on measuring chokeberry, Nutridrink, immunomodulation, tumor resection
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
Sites / Locations
- Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i OgólneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
Nutridrink Skin Repair
Arm Description
Group of 15 patients undergoing surgical resection of tumour
Group of 15 patients undergoing surgical resection of tumour
Outcomes
Primary Outcome Measures
SOD level
Comparison of SOD level
GSH level
Comparison of GSH level
IL-6 level
Comparison of IL-6 level
IL-8 level
Comparison of IL-8 level
Secondary Outcome Measures
Patients' quality of life
Subjective assessment of patients' quality of life after surgical resection of the tumor (questionnaire). Higher scores mean a better outcome.
Full Information
NCT ID
NCT06017661
First Posted
August 24, 2023
Last Updated
September 28, 2023
Sponsor
AronPharma Sp. z o. o.
1. Study Identification
Unique Protocol Identification Number
NCT06017661
Brief Title
Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection
Official Title
Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AronPharma Sp. z o. o.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunomodulation
Keywords
chokeberry, Nutridrink, immunomodulation, tumor resection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
Arm Type
Experimental
Arm Description
Group of 15 patients undergoing surgical resection of tumour
Arm Title
Nutridrink Skin Repair
Arm Type
Active Comparator
Arm Description
Group of 15 patients undergoing surgical resection of tumour
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
Intervention Description
2 times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutridrink Skin Repair
Intervention Description
2 times a day
Primary Outcome Measure Information:
Title
SOD level
Description
Comparison of SOD level
Time Frame
Baseline, 3 weeks, 6 weeks
Title
GSH level
Description
Comparison of GSH level
Time Frame
Baseline, 3 weeks, 6 weeks
Title
IL-6 level
Description
Comparison of IL-6 level
Time Frame
Baseline, 3 weeks, 6 weeks
Title
IL-8 level
Description
Comparison of IL-8 level
Time Frame
Baseline, 3 weeks, 6 weeks
Secondary Outcome Measure Information:
Title
Patients' quality of life
Description
Subjective assessment of patients' quality of life after surgical resection of the tumor (questionnaire). Higher scores mean a better outcome.
Time Frame
Baseline, 3 weeks, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólne
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Khaidakov, PhD
Phone
798 210 651
Ext
+48
Email
barbara.khaidakov@aronpharma.pl
First Name & Middle Initial & Last Name & Degree
Piotr Spychalski
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection
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