Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation

Официальное название

A Phase II Randomized Trial of Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation

Обзор

This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Eligible patients will be randomized to receive standard of care (e.g., initiation of supplemental nutrition when oral intake declines) versus enteral nutrition via enteral feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment. The primary endpoint will be cumulative incidence of stage 3-4 acute GVHD of the lower gut by day +100 post-transplant, whereas secondary endpoints will be stage 2-4 acute GVHD of the lower gut by day +100, grade 2-4 acute GVHD, weight loss and changes in lean muscle mass, changes in physical function, health-related quality of life, length of transplant hospital stay, and time to platelet and neutrophil engraftment. Assessments will include acute GVHD assessments and grading, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Fried Frailty Index, and Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).

Вмешательства

• Пищевая добавка Enteral Nutrition
  A commercially available blenderized tube feed nutrition (BTF) formula will be initiated at a fixed starting rate of 25 ml/hr. The infusion rate will be increased in consultation with a registered dietitian nutritionist (RDN) based on tolerance to reach a feeding goal of 30-35 kcal/kg/day, which includes 1.5-2 g of protein/kg/day.

Первичные конечные точки

• Incidence of Stage 3-4 Acute GVHD of Lower Gut [Срок оценки: 100 Days post- transplant]

Вторичные конечные точки (10)

• Incidence of Stage 2-4 Acute GVHD of Lower Gut [Срок оценки: 100 Days post- transplant]
• Percent change in weight [Срок оценки: Day +30 and Day +100 post-transplant]
• Percent change in lean body mass [Срок оценки: Baseline and Day +30 post-transplant]
• Health-Related Quality of Life (HRQoL) [Срок оценки: Baseline and Day +100 post-transplant]
• Transplant hospital stay [Срок оценки: Up to approximately 30 Days Post Transplant]
• Platelet and neutrophil engraftment [Срок оценки: Aproximately14 days post-transplant]
• Functional status and physical performance [Срок оценки: Day +30, and Day +100 post-transplant]
• Functional status and physical performance Activities of Daily Living (ADL) [Срок оценки: Day +30, and Day +100 post-transplant]
• Functional status and physical performance Instrumental Activities of Daily Living (IADL) [Срок оценки: Day +30, and Day +100 post-transplant]
• Functional status and physical performance [Срок оценки: Day +30, and Day +100 post-transplant]

Критерии участия

Критерии включения

• Diagnosis of a hematological condition or serious blood disorder
• Patient planned for an allogeneic hematopoietic stem cell transplant
• Any conditioning regimen or graft source

Критерии исключения

• Uncorrected anatomical deformity of the nose, nasopharynx, esophagus, or stomach that could prevent proper placement of a nasogastric tube.
• Chronic gastrointestinal conditions causing malabsorption or need for nutritional supplementation, e.g., celiac disease, short gut syndrome, chronic use of total parental nutrition or enteral nutrition for 3 or more months. Uncorrected anatomical deformity may include any known significant deviated nasal septum, large nasal polyps or other masses, or nasal or oropharyngeal trauma.

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 & Pamela Buffet Cancer Center — Omaha

Идентификаторы

NCT: NCT07315165 · 213-26-FB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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