Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers

Официальное название

Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study

Обзор

Patients with locally advanced non-metastatic adenocarcinoma of the rectum undergoing chemoradiation therapy will be assigned to 2 groups: * the intervention group will be prescribed an individualized ketogenic eating plan to be followed throughout the treatment period * the control group will be prescribed a diet therapy plan treatment following the international guidelines of clinical nutrition, also to be followed during treatment

Подробное описание

Some days before the start of radiotherapy there will be the first visit in which patients will be enrolled and placed in one of the following two groups:

* The intervention group (KD) will be prescribed a ketogenic diet therapy plan characterized by the following composition: carbohydrates \< 30g/day, 1.2g-1.5g protein/kg/day and lipids \> 65%. * The control group (SD) will be prescribed a nutrition plan based on the Mediterranean diet model according to ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%) There will then be two additional follow-ups for patients: one during the period of therapy and one at the end of therapy.

Compliance with diet therapy treatment (SD vs. KD) will be assessed by analysis of a food diary that the patient will be asked to complete.

During follow-ups it will be assessed:

* BMI and body composition (by bioimpedance analysis) * Muscle strength and physical performance (by hand grip test and sit-to-stand test) Compliance with and toxicity of radiochemotherapy treatment will be assessed at the radiochemotherapy visits (3 visits during treatment)

Вмешательства

• Другое Ketogenic Diet
  In the group of intervention is prescribed a ketogenic diet plan characterized by the following composition: carbohydrates \< 30g/day, 1.2g-1.5g protein/kg/day and lipids \> 65%. This diet will be followed during the period of treatment with chemo-radiotherapy (5 weeks)
• Другое Standard Diet
  The control group (SD) will follow the Mediterranean diet pattern based on ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%).

Первичные конечные точки

• Adherence to the ketogenic diet [Срок оценки: 2 months]

Вторичные конечные точки (7)

• Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group [Срок оценки: 2 months]
• Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group [Срок оценки: 2 months]
• Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response [Срок оценки: 2 months]
• Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response [Срок оценки: 2 months]
• Evaluation of the tolerability to the treatment [Срок оценки: 2 months]
• Evaluation of the response to the treatment [Срок оценки: 2 months]
• Investigate indices of quality of life [Срок оценки: 2 months]

Критерии участия

Критерии включения

• Histologic confirmation of rectal adenocarcinoma
• Locally advanced rectal cancer
• Patients undergoing neoadjuvant radiotherapy treatment
• Signature of informed consent to the processing of personal data

Критерии исключения

• Severely malnourished patients according to GLIM (Global Leadership Initiative on Malnutrition) criteria
• Patients treated for palliative purposes
• Patients with metastatic disease
• Diabetes mellitus
• Pregnancy or lactation
• Significant food allergies that would make the person unable to consume the food provided
• Refusal to participate in the proposed clinical trial

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Rome

Идентификаторы

NCT: NCT05938322 · 5812

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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