A Dietary Study for People With Clonal Hematopoiesis

Официальное название

A Decentralized High-Fiber Dietary Intervention Trial in Clonal Hematopoiesis - NUTRIVENTION-CH

Обзор

The researchers are doing this study to find out whether a high-fiber plant-based diet (HFPBD) can improve quality of life for people with CH. A HFPBD includes foods that are mainly from plants (for example, fruits,vegetables, nuts, beans, and whole grains). The researchers will measure quality of life by having participants complete questionnaires/surveys.

Вмешательства

• Другое high-fiber plant-based meals
  A meal service will ship 12 frozen prepared meals per week to your home.
• Другое fermented foods
  Fermented foods will be encouraged on the diet. Fermented foods contain probiotics that help support a balanced gut microbiome and might improve overall digestion.
• Пищевая добавка supplements
  Patients will be recommended by research dietitian to take a weekly vitamin B12 supplement (at least 500 mcg weekly)
• Другое surveys
  QOL will be measured with the EORTC QLQ C30

Первичные конечные точки

• compare the rates of improvement in Quality Of Life [Срок оценки: up to 12 weeks]

Критерии участия

Критерии включения

• Patients must have confirmed clonal hematopoiesis via next generation sequencing (NGS) of blood or bone marrow biopsy sample
• Patients with clonal cytopenias of undetermined significance (CCUS) are eligible if a bone marrow biopsy is done to exclude other causes.
• Variant allele frequency must be ≥2% for mutation as measured by (NGS)
• Treatment at MSK or at sites listed below that uses EPIC for electronic medical records and willing to share records with MSK through EPIC's care everywhere or through MSK's shared care network. If not meeting this criterion, decision to allow for participation is per PI discretion.
• Age ≥ 18 years
• BMI ≥25 kg/m\^2
• Participant or caregiver must be able to complete surveys and have interest in trying new recipes or cooking.
• Screening 24-hour dietary recall must consume <30 grams dietary fiber per day to be eligible (any one of two 24-hour screening dietary recalls).
• For patients at MSK, require bone marrow biopsy at screening in the past 24 weeks with collection of research biobanking sample. Bone marrow at other sites is optional.

Критерии исключения

• Prior MDS/AML directed therapy
• Chemotherapy, radiation, or immunotherapy within the past year (surgical- resection only or other cancer/precancer on observation is eligible)
• Patients with a concurrent malignancy whose natural history or treatment may compromise completion of this trial are excluded.
• Concurrent pregnancy will make a participant ineligible to participate
• Patients that already follow a minimally processed (whole food) plant-based diet in the last 3 months are not eligible (ovo-lacto-vegetarian or processed junk food vegan diets are eligible).
• Patients on GLP-1 drugs are eligible if it has been started at least 3 months prior to study and on stable dose. If it has been started more recently for diabetes mellitus control but not weight loss they are eligible. If it is medically indicated and started for diabetes mellitus control while on trial they will not be removed/excluded from trial.
• Mental impairment leading to inability to cooperate will lead to exclusion from trial participation.
• If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications.
• Concurrent weight loss or dietary programs will be ineligible if require a specific diet or weight loss supplements.
• Plan for prolonged travel during the study that would preclude adherence to prescribed diet. Willingness to comply during travel is not an exclusion.
• Severe allergy to any legume (such as anaphylactic shock) or allergies to multiple legumes or if cross-contamination is a risk are not eligible.
• Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews are not eligible.

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

Профилактика

Центры проведения

США · 7 центров

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
• Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale

Идентификаторы

NCT: NCT07590804 · 26-086

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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