Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Obesity

Multiple Myeloma

Neoplasms, Plasma Cell

Weight Loss

Body Weight

Smoldering Multiple Myeloma

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Body Weight Changes

Lymphatic Diseases

The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times they record via the text messaging system. The text messaging system will be used throughout the duration of the study.

For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study

promote a 14-hour fast during the nighttime hours

Prolonged Fasting Intervention

introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living

EDUCATION CONTROL

Catherine Marinac, Ph.D

Catherine Marinac, PhD

This is a 4-month randomized trial of a prolonged nightly fasting intervention (PROFAST) in 40 overweight and obese individuals with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and smoldering waldenstrom macroglobulinemia (SWM). The purpose of this study is to understand if fasting for a prolonged period of time during the nighttime hours is a strategy to prevent overweight and obese individuals from developing blood cancer.

Participants will be randomized into the following two groups:

* Group A: PROFAST intervention for 4 months
* Group B: Healthy Lifestyle Control group for 4 months

The purpose of this research study is to learn if fasting for a prolonged period of time could be used in the future to help improve body composition and prevent blood cancer in overweight and obese individuals with MGUS, SMM, and SWM. Multiple myeloma is a cancer of the plasma cells, which is an important part of the immune system. Participants with active multiple myeloma generally require treatment. There are currently no approved therapies or prevention strategies for smoldering multiple myeloma or monoclonal gammopathy of undetermined significance.

The National Cancer Institute of the National Institutes of Health is supporting this research study by providing funding.

This research study is a 4-month randomized trial of prolonged nightly fasting (PROFAST). It is expected that about 40 people will take part in this research study. The total study duration is 4 months.

Participants in the study will be randomized, in equal numbers to either the nightly fasting intervention group or a control group.

* The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times via the text messaging system. The text messaging system will be used throughout the duration of the study.
* For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study.

PROFAST Intervention in Precursor Multiple Myeloma

PROlonged Nightly FASTing for Obesity Reduction and Prevention of Disease Prevention in Precursor Multiple Myeloma (PROFAST)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Monoclonal (M-)proteins produced in excess by an abnormal clonal proliferation of plasma (MM) cells that can be measured in the serum using Serum Protein Electrophoresis (SPEP) and the Serum Free Light Chain Assay.

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PROFAST Intervention in Precursor Multiple Myeloma	NCT05565638	Cancer Preventi... Weight Loss Smoldering Wald... MGUS Fasting Multiple Myelom...	Prolonged Fasti... EDUCATION CONTR...	18 Years -	Dana-Farber Cancer Institute
PROFAST Intervention in Precursor Multiple Myeloma	NCT05565638	Cancer Preventi... Weight Loss Smoldering Wald... MGUS Fasting Multiple Myelom...	Prolonged Fasti... EDUCATION CONTR...	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for smoldering waldenstrom macroglobulinemia(wm)