Идёт набор NCT05832606

Food Intervention to Reduce Immunotherapy ToXicity

Без фазы С лечением Immune-related Adverse Event Dietary Habits

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Food box containing 30 different plants.
Кому может быть актуально: Состояния в реестре: Immune-related Adverse Event, Dietary Habits. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The FORX (Food intervention to Reduce immunotherapy toXicity) trial will assess whether supplementing dietary fiber intake by providing weekly boxes containing 30 different plants to patients with solid tumors starting immune checkpoint inhibitor therapy affects the incidence of immune related adverse events.

Подробное описание

Immune checkpoint inhibitor (ICI) therapy has revolutionized cancer treatment but can give rise to immune related adverse events (irAEs) that are currently not preventable. These irAEs impact patients' quality of life and oncological treatment course. The gut plays an essential role in immune homeostasis and gut dysbiosis is implicated in (auto)inflammatory conditions. The FORX trial investigates whether the composition of the gut microbiome can be altered to improve ICI tolerance. It has been shown that healthy volunteers who ingest at least 30 different plants (vegetables, fruits, nuts) weekly, have a more diverse microbiome than those who consume 10 or less. A fiber-rich diet has been associated with improved outcome of ICI treatment. This trial is the first prospective trial to translate these findings into a concrete dietary advice. The diets of patients with a solid tumor who start ICI will be supplemented by weekly boxes containing 30 different plants during the first 12 weeks of their treatment. The increased fiber intake is expected to strengthen the gut microbiome and reduce the incidence of irAEs. Stool and blood samples will clarify the microbial and cytokine signatures associated with irAEs. The FORX trial will provide valuable insights in the interaction between the gut microbiome and autoimmunity and serve as a basis for nutritional advice and the development of targeted probiotics. It will empower cancer patients and improve their quality of life.

Вмешательства

Другое Food box containing 30 different plants
Food boxes during first 12 weeks of therapy. Clinical follow-up until end of immunotherapy.

Первичные конечные точки

Feasibility of performing a dietary intervention trial in our center [Срок оценки: 12 weeks]
Incidence of immune related adverse events [Срок оценки: up to 24 months]

Вторичные конечные точки (4)

Response rate [Срок оценки: up to 48 weeks]
Quality of life [Срок оценки: 12 weeks]
Changes in gut microbiota [Срок оценки: 12 weeks and in case of an irAE up to 48 months]
Assess changes in cytokines and immune cell subsets associated with irAEs [Срок оценки: 12 weeks and in case of an irAE up to 48 months]

Критерии участия

Критерии включения

solid tumor starting anti-programmed cell death protein 1 (anti-PD1) and/or anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA4) antibodies as part of standard of care.
able to sign informed consent.