Идёт набор NCT05417867

Evaluating the Association Among Changes in Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer

— Наблюдательное Chemotherapy-Related Nausea and/or Vomiting Early Stage Breast Carcinoma Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8

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, Questionnaire Administration.
Кому может быть актуально: Состояния в реестре: Chemotherapy-Related Nausea and/or Vomiting, Early Stage Breast Carcinoma, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8. Базовые параметры: от 20 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

Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles

Обзор

This pilot study seeks to understand how changes in the bacteria composition (microbiome) of the gut may be associated with the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for early stage breast cancer. Patients undergoing chemotherapy may experience fatigue or nausea as a result of their treatment. Known risk factors for fatigue and CIN do not explain the differences in fatigue and CIN occurrence between patients, but changes in the functions of the gut microbiome may be related to the occurrence of fatigue and CIN. This study collects stool samples from breast cancer patients before and after chemotherapy to evaluate how changes in the microbiome may be associated with fatigue and CIN.

Подробное описание

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of patient recruitment and retention, as well as specimen collection.

II. Estimate the effect size for changes in gut microbiome composition profiles and metabolites in stool as well as blood from time of first stool sample collection prior to chemotherapy (T1) to time of second stool sample collection after chemotherapy (T2) that are associated with the occurrence of fatigue and CIN.

III. Evaluate associations between patient reported demographic and clinical characteristics, comorbidities at T1, and changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 with the occurrence of fatigue and CIN.

OUTLINE: This is an observational study.

Patients undergo collection of stool and blood samples and complete questionnaires on study.

Вмешательства

Процедура Biospecimen Collection
Undergo collection of stool and blood samples
Другое Questionnaire Administration
Complete questionnaires

Первичные конечные точки

Number of patients approached [Срок оценки: Up to 24 months]
Number of patients enrolled [Срок оценки: Up to 24 months]
Number of patients who completed the questionnaires at both assessments [Срок оценки: At baseline and 3-5 days after initiation of chemotherapy]
Number of patients who provided stool samples at both assessments [Срок оценки: At baseline and 3-5 days after initiation of chemotherapy]
Bacterial composition of stool samples [Срок оценки: Up to study completion]
Differences in demographic between patients who do and do not report fatigue and CIN [Срок оценки: Up to study completion]
Differences in clinical characteristics between patients who do and do not report CIN [Срок оценки: Up to study completion]
Differences in comorbidities between patients who do and do not report CIN [Срок оценки: Up to study completion]

Критерии участия

Критерии включения

Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida
At least 20 years of age
Last chemotherapy more than 3 years ago
Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies