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Идёт набор NCT07622914

The Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer

Наблюдательное Head and Neck Cancers

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: Head and Neck Cancers. 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 →
Официальное название

A Preliminary Elucidation of the Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer

Обзор

Emerging data suggest consumption of dietary fiber before and during cancer treatment may improve prognosis for patients with head and neck cancer, in part via increased production of short chain fatty acids, systemic anti-inflammatory effects, and decreased risk of sarcopenia. Foods rich in dietary fiber are often low in calories and protein, thus are not typically targeted in current treatment paradigms that focus on countering the catabolic state associated with sarcopenia. This project entails an observational, mixed methods study to: observe dietary fiber intake in patients with head and neck cancer from time of diagnosis for six months; elucidate the relationship between dietary fiber intake, short chain fatty acids, inflammatory markers, and sarcopenia; and explore the feasibility of and patient perceptions regarding promoting dietary fiber as part of their treatment approaches.

Подробное описание

Sarcopenia remains a consequential prognostic factor that drastically affects morbidity and mortality in head and neck cancer (HNC). Due to the catabolic state associated with sarcopenia, dietary strategies emphasizing energy and protein intake are often encouraged. However, data suggest underlying mechanisms (e.g., inflammation) drive the development of sarcopenia independent of energy or protein intake. Dietary fiber is notably anti-inflammatory and has capacity to improve sarcopenia and other cancer-related outcomes, in part via production of short chain fatty acids (SCFA) and decreased inflammation. This precise relationship is yet explored in HNC. Moreover, it is unknown how patients perceive the feasibility of increasing their dietary fiber intake during treatment. This study seeks to evaluate dietary fiber intake longitudinally from the time of diagnosis for a total of six months in patients diagnosed with HNC, and to elucidate the relationship between dietary fiber intake and measures of SCFA, inflammation, and sarcopenia. Adults newly diagnosed with HNC will be recruited and provide iterative assessments of dietary fiber intake (National Cancer Institute Diet History Questionnaire III \[DHQIII\] and 24-hour recalls), SCFA (stool samples analyzed using gas-phase chromatography), inflammatory markers (venous blood samples and multiplex kits), skeletal muscle quantity and quality (CT scans analyzed using SliceOMatic), muscle function (Timed Chair Stands, Leg Press Power), and perceptions regarding the feasibility of targeting dietary fiber (semi-structured interviews \[SSIs\], surveys). Our central hypothesis is that lower dietary fiber intake will significantly predict development of sarcopenia, decreased SCFA, and increased inflammatory markers. In Aim 1, we will determine the relationship between dietary fiber intake, SCFA, inflammatory markers, and skeletal muscle measures in patients being treated for HNC. In Aim 2, we will characterize the feasibility (acceptability, demand, practicality, implementation) of targeting dietary fiber in patients with HNC according to patient perceptions (SSIs, surveys) within Health Belief Model constructs and review of study records (e.g., retention, completion of data collection). This proposal will generate fundamental knowledge and explore the clinical application of this knowledge to support future clinical trials that have the potential to lead to substantial paradigm shifts that could contribute to immense improvements in HNC prognosis.

Первичные конечные точки

  • Dietary Fiber Intake (mean for 30 days) [Срок оценки: Baseline/upon enrollment, 3-months post-enrollment, and 6-months post-enrollment]
  • Skeletal Muscle Index (SMI) [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
Вторичные конечные точки (12)
  • Dietary Fiber Intake (daily) [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Skeletal Muscle Density [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Intramuscular Adipose Tissue (IMAT) [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Body Weight [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Height [Срок оценки: Baseline]
  • Fat Free Mass [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Total Body Water [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Skeletal Muscle Mass [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Whole Body Phase Angle [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Limb Lean Mass [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Limb Intracellular Water [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]
  • Limb Extracellular Water [Срок оценки: Baseline, 3-months post-enrollment, 6-months post-enrollment]

Критерии участия

Критерии включения

  • ≥18 years of age
  • Newly diagnosed with squamous cell carcinoma of the: paranasal sinuses, nasal cavity, oral cavity, tongue, larynx, pharynx \[i.e., nasopharynx, oropharynx, hypopharynx\]
  • Meeting at least 60% of baseline energy needs
  • Willingness to provide data prior to treatment
  • Access to the internet
  • Access to a home freezer
  • Ability to do remote interview
  • Access to a phone
  • Willingness to avoid pre-, pro-, or synbiotics

Критерии исключения

  • Previously diagnosed or positive screen for a GI-related condition or eating disorder
  • Able to complete bioelectrical impedance (stand unsupported, no pacemaker or limb amputation) and Timed Chair Stands
  • Currently pregnant, planning to become pregnant, or breastfeeding
  • Current or past 3-month antibiotic use

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Stephenson Cancer Center — Oklahoma City

Идентификаторы

NCT: NCT07622914 · 18719

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗