Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery

Официальное название

Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery: A Pilot, Prospective, Randomized, Double-Blind, Controlled Study

Обзор

The OMNI study is a clinical trial investigating whether a nutritional supplement with added Omega-3 fatty acids can improve surgical outcomes for patients with peritoneal carcinomatosis. Peritoneal carcinomatosis is a type of cancer that affects the abdominal lining and often requires complex and extensive surgery called cytoreductive surgery (CRS). This procedure is associated with a high risk of postoperative complications, such as infections and long hospital stays. Omega-3 fatty acids are known for their anti-inflammatory and immune-modulating properties. The study's main goal is to see if a 21-day regimen of a pre-operative Omega-3 enriched oral nutritional supplement (ONS) can reduce postoperative complications, as measured by the Clavien-Dindo classification. Who can participate? The study is recruiting patients over 18 years old who have been diagnosed with non-gynecological peritoneal carcinomatosis and are scheduled to undergo cytoreductive surgery and HIPEC (hyperthermic intraperitoneal chemotherapy). What does participating involve? Upon joining the study, participants will be randomly assigned to one of two groups: * Intervention Group: Participants will receive an Omega-3 enriched nutritional supplement called Fortimel Forticare. * Control Group: Participants will receive a standard nutritional supplement called Fortimel Compact Protein. Both groups will be asked to consume two bottles of their assigned supplement per day for 21 days before the scheduled surgery. What will be measured? Throughout the study, the investigators will perform various assessments to monitor participant health and recovery: * Before and after surgery: The investigators will take body measurements, conduct a bioimpedance analysis (BIA) to check body composition, and perform a Hand Grip test to measure muscle strength. The investigators will also collect blood and stool samples. * During surgery: The investigators will collect tissue samples to study the tumor environment. * After surgery: The investigators will track patient recovery, including the length of the hospital stay and any complications that may occur. The investigators will also continue to monitor certain markers in the patients' blood. The study is expected to enroll a total of 28 patients.

Вмешательства

• Пищевая добавка ONS enriched with Omega-3
  300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 0.65, 1465 mg ω3 per bottle
• Пищевая добавка Standard ONS
  300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 5.07 per bottle

Первичные конечные точки

• Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification [Срок оценки: Frome the surgical intervention to 60-days after surgery]

Вторичные конечные точки (5)

• Evaluation of variations in serum levels of specific inflammatory cytokines (IL-6, IL-10, and TNF-alpha) [Срок оценки: From baseline (1 day before surgery) up to 7 days after surgery]
• Evaluation of targeted metabolomic changes in blood (including amino acids, bile acids, and biogenic amines) [Срок оценки: From enrollment (T0) to the day before surgery (T1), an estimated period of 21 days]
• Evaluation of changes in gut microbiota composition and diversity, assessed via 16S rRNA gene sequencing of stool samples. [Срок оценки: From enrollment (T0) to the day before surgery (T1), an estimated period of 21 days]
• Compliance with prescribed ONS (percentage of ONS taken of the total prescribed) [Срок оценки: From enrollment to the day before surgery]
• Changes in the Tumor Microenvironment Assessed by Transcriptomic Analysis [Срок оценки: From the enrollment (T0) to the Cytoreductive Surgery + Hipertermic Intraperitoneal Chemotherapy (T1)]

Критерии участия

Критерии включения

• Age > 18 years
• Diagnosis of peritoneal carcinomatosis from a non-gynecological primary neoplasm
• Patients who must undergo cytoreductive surgery and HIPEC
• Signed informed consent form

Критерии исключения

• Patients with an enterocutaneous fistula
• Patients with known food allergies
• Age < 18 years
• Patients with severe organ damage (e.g., kidney failure, liver failure)
• Refusal to sign the informed consent form

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Clinical Nutrition Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma

Идентификаторы

NCT: NCT07478432 · ID 7814

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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