Идёт набор NCT06098404

Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

— Наблюдательное Cancer

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Cancer. 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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Обзор

The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.

Подробное описание

Cancer-related fatigue is experienced by nearly all patients during treatment, and cancer-related cognitive impairment (CRCI), which is a decrease in neurocognitive functioning that can be caused by cancer or its treatment, is present in up to ¾ of patients during treatment. Fatigue and CRCI have both been linked to the composition of the gut microbiome in cancer patients. CRCI is often reported as one of the most debilitating and life-altering aspects of cancer and treatment. Although CRCI is widely reported in patients with a variety of cancers and undergoing a variety of treatments, it is not clear if the mechanisms leading to symptoms are the same throughout. Using identical methods to monitor CRCI symptoms and microbial dysbiosis in a cross-section of various cancers, cancer stages, and treatments, can help to identify commonalities associated with symptoms.

Specific Aims

Specific Aim 1: Characterize the microbiome of cancer patients and compare to healthy control subjects from previous studies.

Specific Aim 2: Assess fatigue in cancer patients and determine associations with composition of the gut microbiome.

Первичные конечные точки

Characterization of fecal microbiome using molecular methods at baseline [Срок оценки: Baseline]
Characterization of fecal microbiome using molecular methods at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (6)

Cognitive Function as measured by Montreal Cognitive Assessment at baseline [Срок оценки: Baseline]
Cognitive Function as measured by Montreal Cognitive Assessment at 6 months [Срок оценки: 6 months]
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline [Срок оценки: Baseline]
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months [Срок оценки: 6 months]
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline [Срок оценки: Baseline]
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at 6 months. [Срок оценки: 6 months]

Критерии участия

Критерии включения

Current diagnosis of cancer.
Ages 18 and over.
Has access to a device (smart phone, computer, tablet) with internet access.
Participant is willing and able to give informed consent for participation in the study.