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

AronPharma

Status: Enrolling

Conditions: Immunomodulation

Treatments: Dietary Supplement: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds; Dietary Supplement: Nutridrink Skin Repair

Study type: Interventional

Funder types: Industry

Identifiers

NCT06017661

09-AP-ONCON

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds

Experimental group

Description:

Group of 15 patients undergoing surgical resection of tumour

Treatment:

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

Nutridrink Skin Repair

Active Comparator group

Description:

Group of 15 patients undergoing surgical resection of tumour

Treatment:

Dietary Supplement: Nutridrink Skin Repair