Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection

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.

Study Overview

• Status: Recruiting
• Conditions: Immunomodulation
• Intervention / Treatment: Dietary supplement: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds; Dietary supplement: Nutridrink Skin Repair

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland, 80-214
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólne
    • Contact: Barbara Khaidakov, PhD; Phone Number: +48 798 210 651; Email: barbara.khaidakov@aronpharma.pl
    • Principal Investigator: Piotr Spychalski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds; Group of 15 patients undergoing surgical resection of tumour	Dietary supplement: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds; 2 times a day
Active Comparator: Nutridrink Skin Repair; Group of 15 patients undergoing surgical resection of tumour	Dietary supplement: Nutridrink Skin Repair; 2 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOD level	Comparison of SOD level	Baseline, 3 weeks, 6 weeks
GSH level	Comparison of GSH level	Baseline, 3 weeks, 6 weeks
IL-6 level	Comparison of IL-6 level	Baseline, 3 weeks, 6 weeks
IL-8 level	Comparison of IL-8 level	Baseline, 3 weeks, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' quality of life	Subjective assessment of patients' quality of life after surgical resection of the tumor (questionnaire). Higher scores mean a better outcome.	Baseline, 3 weeks, 6 weeks

Collaborators and Investigators

• Sponsor: AronPharma Sp. z o. o.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: immunomodulation; chokeberry; tumor resection; Nutridrink
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: 09-AP-ONCON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No