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Идёт набор NCT06438588

Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors, FMD-ICI Trial

Без фазы С лечением Advanced Malignant Solid Neoplasm

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: Biospecimen Collection, Dietary Intervention, Educational Intervention, Electronic Health Record Review.
Кому может быть актуально
Состояния в реестре: Advanced Malignant Solid Neoplasm. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Fasting Mimicking Diet (FMD) on Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors: The FMD-ICI Feasibility Pilot Study

Обзор

This clinical trial assesses an effective and translatable care model to understand and reduce the adverse effects that cancer patients experience during their treatment therapies and thereby enhance their well-being and quality of life. Excessive immune activation can affect multiple organs with the most common adverse effects being skin rash, diarrhea, colitis, fatigue, hypothyroidism and anorexia. A restrictive calorie diet, mostly of fat and complex carbohydrates, will mimic fasting and increase resiliency to protect patients from the adverse effects of cancer treatments, by managing the adverse side effects of immune checkpoint inhibitors (ICI) treatments in select cancer patients. The fast mimicking diet (FMD) (Xentigen®) is a calorie restrictive, low-calorie, low-protein, high complex carbohydrate, high-fat diet. The FMD program is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consists of 100% ingredients which are generally regarded as safe (GRAS) and comprises mainly of vegetable-based soups and broths, energy bars, energy drinks, cracker snacks, herbal teas, and supplements. Following a FMD may reduce the adverse effects that some cancer patients experience while following immunotherapy treatments.

Подробное описание

PRIMARY OBJECTIVES:

I. Assess the impact of immunotherapy + FMD/Xentigen® on immune related adverse events rates (irAEs) (including immune-mediated colitis).

II. Appraise the impact of immunotherapy + FMD/Xentigen® on the patient's physical function and quality of life.

III. Evaluate the impact of immunotherapy + FMD/Xentigen® on surrogate markers of inflammation (i.e., fecal calprotectin) as a predictive marker of immune-mediated colitis.

OUTLINE:

Patients receive nutrition counseling with a nutritionist over 60 minutes, receive FMD over 4 days for 3 cycles of immunotherapy and educational guidelines for day 5 to transition to a regular diet. Patients undergo blood sample collection throughout the study.

Upon completion of study intervention, patients are followed up at 6 months.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo blood sample collection
  • Другое Dietary Intervention
    Given FMD
  • Другое Educational Intervention
    Receive educational guidelines
  • Другое Electronic Health Record Review
    Ancillary studies
  • Другое Interview
    Ancillary studies
  • Другое Nutritional Assessment
    Receive nutrition counseling
  • Другое Questionnaire Administration
    Ancillary studies

Первичные конечные точки

  • Symptom Measurement [Срок оценки: Up to 6 months]
  • Incidence of adverse events [Срок оценки: Up to 6 months]
  • Physical function [Срок оценки: Up to 6 months]
  • Quality of life - FACT-G [Срок оценки: Up to 6 months]
  • Fecal calprotectin [Срок оценки: At baseline, week 12 and week 24]

Критерии участия

Критерии включения

  • Patients undergoing immunotherapy regardless of prior immunotherapy history
  • Age ≥ 18 years
  • Body mass index (BMI) > 19
  • Histological confirmation of advanced staged malignancies (stage 3 or 4) appropriate for the following types of immunotherapy: PD-1 Antibody (nivolumab, pembrolizumab), PD-L1 Antibody (atezolizumab, avelumab, durvalumab), CTLA-4 Antibody (ipilimumab) or any combination thereof

Критерии исключения

  • Age < 18 years
  • Pregnant women
  • Nursing mothers
  • Persons of childbearing potential who are unwilling to employ adequate contraception
  • Patients will be excluded if they are on insulin due to diabetes \[diabetic patients will be asked to monitor their glucose levels with a continuous glucose monitoring (CGM) device\], if they have allergies to any of the components in the FMD, if there is unacceptable deterioration of their nutritional status and cancer progression

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT06438588 · 20-012936

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗