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

Immunomodulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017661
• Other study ID #: 09-AP-ONCON
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: August 2023
• Source: AronPharma Sp. z o. o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Immunomodulation

Intervention

Dietary Supplement:
• Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
2 times a day
• Nutridrink Skin Repair
2 times a day

Locations

Country	Name	City	State
Poland	Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólne	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
AronPharma Sp. z o. o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SOD level	Comparison of SOD level	Baseline, 3 weeks, 6 weeks
Primary	GSH level	Comparison of GSH level	Baseline, 3 weeks, 6 weeks
Primary	IL-6 level	Comparison of IL-6 level	Baseline, 3 weeks, 6 weeks
Primary	IL-8 level	Comparison of IL-8 level	Baseline, 3 weeks, 6 weeks
Secondary	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