Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors

Официальное название

A Randomized Controlled Trial Testing the Effects of an Exercise Intervention on the Gut Microbiota in Colorectal Cancer Survivors: A Pilot and Feasibility Study

Обзор

This trial evaluates the effects a moderate-to-vigorous exercise intervention has on the bacterial make-up of the gastrointestinal tract (gut microbiota) in survivors of stage II-III colorectal cancer (CRC). Data shows that the gut microbiota composition and function may be drivers of CRC. High levels of exercise are associated with improved CRC prognosis and survival. While data suggests that exercise has the potential to influence gut microbiota composition and function, it is not known whether these effects contribute to improved CRC prognosis. This clinical trial evaluates the effects an exercise intervention has on gut microbiota and how these effects relate to CRC progression and patient-reported outcomes.

Подробное описание

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive the supervised exercise intervention (in-person or virtual) three times weekly (TID) over 8 weeks on study. Patients also undergo collection of blood samples on study.

ARM B: Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.

Вмешательства

• Процедура Biospecimen Collection
  Undergo collection of blood samples
• Другое Exercise Intervention
  Receive exercise intervention
• Другое Exercise Intervention
  Receive tele-coaching intervention
• Поведенческое Health Education
  Receive health-related information
• Другое Interview
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Recruitment [Срок оценки: Up to 8 weeks]
• Adherence [Срок оценки: Up to 8 weeks]
• Retention [Срок оценки: Up to 8 weeks]
• Acceptability [Срок оценки: Up to 8 weeks]

Вторичные конечные точки (2)

• Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate [Срок оценки: At 8 weeks]
• Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids [Срок оценки: At 8 weeks]

Критерии участия

Критерии включения

• 18-70 years of age
• Previous diagnosis of stage II-III CRC cancer
• No known current, recurrent, or metastatic disease
• No comorbid or physical limitations that would limit participation at the discretion of the treating provider
• At least 60 days to 3 years from last cancer-directed treatment (including surgery, chemotherapy, and radiation. Elective surgery, including ileostomy reversal, is not counted in this timing but patients must be able to eat a normal diet, without post-operative dietary limitations)
• Body mass index (BMI) 18.5-35 kg/m\^2
• Able to understand and willing to sign written informed consent in English
• Access to phone for study contacts
• Access to a smart phone or tablet to connect to the Polar H10 Heart rate sensor during remote exercise sessions and attend virtual exercise sessions
• Be willing and able to attend up to 24 sessions in-person at the Fred Hutch Exercise Research Center Shared Resource or virtually via phone, Zoom, or Microsoft Teams, based on participant preference
• Access to internet (internet access may be provided on a case-by-case basis to participants where access to internet would otherwise be the only barrier to participation)
• Willingness to participate in all study activities
• Completion of all run-in activities
• Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status
• Women must not be pregnant, breastfeeding, or planning to become pregnant

Критерии исключения

• Use of oral or intravenous antibiotics, antifungals, or antiparasitics during the past 6 months
• Presence of an ileostomy or colostomy because of known changes to the gut microbiome with ileostomies and colostomies
• Current status of underweight (BMI < 18.5 kg/m\^2) or class II/III obesity (BMI ≥ 35.0 kg/m\^2)
• Presence of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis as these are known to baseline have differences in gut microbiome composition
• Women who are pregnant, breastfeeding, or planning to become pregnant
• Physician notification to not approach patient for the study

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

США · 1 центр

• Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

NCT: NCT05930496 · RG1123467 · NCI-2023-03747 · P30CA015704 · 20059

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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