FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease

Официальное название

Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease (the FAST-M Study)

Обзор

The purpose of this study is to find out whether a dietary approach that includes prolonged overnight fasting, guided by a Mediterranean-style eating pattern, is feasible for patients with myeloma precursor disease or newly diagnosed multiple myeloma.

Вмешательства

• Поведенческое Health Coaching
  Participants will receive weekly health coaching sessions via telephone, video call, or in-person. The health coach will contact the participant after randomization to begin the intervention, which will include education on POF and following a Mediterranean diet. Sessions are expected to last 30-45 minutes and may be divided per participant preference. Participant safety and well-being will be addressed at each session, and modifications to the diet or session schedule will be made as necessary
• Поведенческое Prolonged Overnight Fasting (POF)
  Participants will be instructed to not consume any calorie-containing food/drinks after 8pm and to wait 14 hours after the fasting start before resuming eating the next day. Participants will use the My Wellness Research (MWR) platform to record fasting start and stop times and times food intake daily. Additionally, workbook containing educational materials and guidance to support adherence to POF goals will be provided. In the first two weeks, participants will be encouraged to fast for at leas
• Поведенческое Mediterranean Diet
  Participants will be encouraged to adopt key components of the Mediterranean diet, including consuming 4+ vegetable servings (2.5-3 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week.
• Поведенческое Supportive Materials
  Participants in the intervention arm will be provided with a workbook with information and support to encourage meeting the POF and Mediterranean diet goals. Additionally, participants will be requested to utilize the My Wellness Research (MWR) platform to track their dietary goals as well as a Fitbit. For participants who choose not to use the app, a paper diet tracking sheet will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message t

Первичные конечные точки

• Feasibility: Percentage of Participants That Agree to Participate [Срок оценки: Baseline]
• Retention Rate Among Participants Assigned to the Intervention Arm [Срок оценки: Up to 35 weeks (8 months)]
• Satisfaction Rate Among Participants on Both Arms [Срок оценки: Up to 35 weeks (8 months)]

Вторичные конечные точки (2)

• Calculated changes in relative dose intensity (RDI) and reasons for change. [Срок оценки: Baseline, 24 weeks (6 months), up to 35 weeks (8 months)]
• Reason for changes in relative dose intensity (RDI). [Срок оценки: Baseline, 24 weeks (6 months), up to 35 weeks (8 months)]

Критерии участия

Критерии включения

• 18 years of age or older.
• Any sex/gender.
• Able to provide consent.
• Able to speak, read, and understand English or Spanish.
• Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), or Multiple Myeloma (MM) per standard criteria:

• Cohort 1 - Participants must have a confirmed diagnosis of MGUS and SMM.
• Cohort 2 - Participants must have a confirmed new diagnosis of MM and be initiating anti-myeloma therapy.
• Delivery of anti-myeloma therapies at one of the following institutions:

• Sylvester Comprehensive Cancer Center (SCCC) (including satellite/network sites).
• University of Miami Health System.
• Approval from treating oncologist, confirmed via email or in writing.
• Eastern Cooperative Oncology Group (ECOG) Performance Status grade of <2

a. PI approval needed if ECOG ≥ 2.

• Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months.
• Not consuming a Mediterranean diet by not meeting 2 or more out of the following 3 Mediterranean eating pattern goals in the prior 3 months: ≥3 servings of vegetables per day, ≥ 3 servings of beans and legumes per week, or ≥ 1 serving of nuts per day.

Mediterranean diet will be screened with select components of a Mediterranean Diet Adherence Screener (MEDAS).

• Internet access on a smart phone, tablet, or computer.
• Willing to be randomized to a prolonged overnight fasting and guided Mediterranean dietary intervention or waitlist-control group.

Критерии исключения

• Individuals younger than 18 years of age.
• Unable to provide consent.
• Unable to read or understand English or Spanish.
• Any contraindication for diet changes as determined by physician.
• History of a clinical eating disorder.
• History of dementia or major psychiatric disease.
• History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure.
• History of autoimmune disease and on treatment at time of screening.

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

Лечение

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT07446777 · 20250792

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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