Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease (the FAST-M Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Feasibility: Percentage of Participants That Agree to Participate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 2: Waitlist Control Group
Participants in this group will not receive any health coaching or study materials until the end of the study four weeks post-intervention, when they will receive one health coaching session, which will describe potential benefits of prolonged overnight fighting (POF) as well as adopting key components of the Mediterranean diet.
Total participation duration is about six (6) months.
干预措施: Mediterranean Diet (Behavioral)
Arm 1: Intervention Group
Participants in this group will receive the FAST-M intervention, which consists of prolonged overnight fasting (POF) and a Mediterranean diet. The intervention will be supported by dietary workbooks, nutrition journals, and a Fitbit to aid in tracking and adherence.
Total participation duration is about six (6) months (24 weeks) for participants with myeloma precursor disease; and about eight (8) months (35 weeks for participants with newly diagnosed multiple myeloma (NDMM). An additional +/- four (4) weeks for catch-up sessions may be added for missed sessions, if necessary.
干预措施: Health Coaching (Behavioral)
Arm 1: Intervention Group
Participants in this group will receive the FAST-M intervention, which consists of prolonged overnight fasting (POF) and a Mediterranean diet. The intervention will be supported by dietary workbooks, nutrition journals, and a Fitbit to aid in tracking and adherence.
Total participation duration is about six (6) months (24 weeks) for participants with myeloma precursor disease; and about eight (8) months (35 weeks for participants with newly diagnosed multiple myeloma (NDMM). An additional +/- four (4) weeks for catch-up sessions may be added for missed sessions, if necessary.
干预措施: Prolonged Overnight Fasting (POF) (Behavioral)
Arm 1: Intervention Group
Participants in this group will receive the FAST-M intervention, which consists of prolonged overnight fasting (POF) and a Mediterranean diet. The intervention will be supported by dietary workbooks, nutrition journals, and a Fitbit to aid in tracking and adherence.
Total participation duration is about six (6) months (24 weeks) for participants with myeloma precursor disease; and about eight (8) months (35 weeks for participants with newly diagnosed multiple myeloma (NDMM). An additional +/- four (4) weeks for catch-up sessions may be added for missed sessions, if necessary.
干预措施: Mediterranean Diet (Behavioral)
Arm 1: Intervention Group
Participants in this group will receive the FAST-M intervention, which consists of prolonged overnight fasting (POF) and a Mediterranean diet. The intervention will be supported by dietary workbooks, nutrition journals, and a Fitbit to aid in tracking and adherence.
Total participation duration is about six (6) months (24 weeks) for participants with myeloma precursor disease; and about eight (8) months (35 weeks for participants with newly diagnosed multiple myeloma (NDMM). An additional +/- four (4) weeks for catch-up sessions may be added for missed sessions, if necessary.
干预措施: Supportive Materials (Behavioral)
Arm 2: Waitlist Control Group
Participants in this group will not receive any health coaching or study materials until the end of the study four weeks post-intervention, when they will receive one health coaching session, which will describe potential benefits of prolonged overnight fighting (POF) as well as adopting key components of the Mediterranean diet.
Total participation duration is about six (6) months.
干预措施: Prolonged Overnight Fasting (POF) (Behavioral)
结局指标
主要结局
Feasibility: Percentage of Participants That Agree to Participate
时间窗: Baseline
Feasibility will be measured as the percentage of participants that consent and agree to participate. Criterion for success: At least (≥) 50% of all eligible participants consent to participate.
Retention Rate Among Participants Assigned to the Intervention Arm
时间窗: Up to 35 weeks (8 months)
The retention rate will be reported as the percentage of participants assigned to the intervention arm who complete all intervention sessions. Criterion for success: At least (≥) 80% of all assigned participants complete intervention sessions across both cohorts: * Cohort 1: Participants with Myeloma Precursor Disease * Cohort 2: Participants with Newly Diagnosed Multiple Myeloma (NDMM)
Satisfaction Rate Among Participants on Both Arms
时间窗: Up to 35 weeks (8 months)
The satisfaction rate among participants on both arms (intervention and waitlist control) will be measured via structured exit interviews and reported. Criterion for success: At least (≥) 80% of all participants report satisfaction with the assigned intervention components on both arms.
次要结局
- Calculated changes in relative dose intensity (RDI) and reasons for change.(Baseline, 24 weeks (6 months), up to 35 weeks (8 months))
- Reason for changes in relative dose intensity (RDI).(Baseline, 24 weeks (6 months), up to 35 weeks (8 months))
研究者
Carl Ola Landgren, MD, PhD
Professor of Clinical
University of Miami