Grant Number:	1R21CA256644-01A1 Interpret this number
Primary Investigator:	Marinac, Catherine
Organization:	Dana-Farber Cancer Inst
Project Title:	Prolonged Nightly Fasting as a Behavioral Intervention for Obesity Reduction and the Prevention of Progression in Precursor Multiple Myeloma
Fiscal Year:	2022

PROJECT SUMMARY Multiple Myeloma (MM) is an incurable and fatal plasma cell dyscrasia that always evolves from the precursor conditions of monoclonal gammopathy of undetermined significance (MGUS) and smoldering MM (SMM). Evidence-based strategies for preventing and intercepting the progression of MGUS/SMM to overt MM are lacking, underscoring the importance of focused research in this area. Substantial evidence indicates that obesity is a risk factor for MM and its precursor conditions. Therefore, interventions that target obesity and/or obesity-related mechanisms of carcinogenesis may serve as possible MM prevention and interception strategies in individuals with MGUS and SMM who are overweight or obese. The research will explore the premise that habitual prolonged nightly fasting is a novel strategy to promote obesity reduction and intercept disease progression in the large proportion of MGUS and SMM patients in the US who are overweight and obese. We focus on prolonged nightly fasting over more traditional multifaceted weight-loss programs because prolonged nightly fasting involves a simple behavior change that most individuals can understand and adopt. We have previously developed a telephone counseling and text messaging-based prolonged nightly fasting (PROFAST) intervention and tested it for one-month in a sample of obese, postmenopausal women at risk for breast cancer and found it to be both achievable and acceptable in that sample of women. The proposed study will build on this prior research by testing a refined version of the PROFAST intervention in a sample of 40 overweight and obese individuals diagnosed with MGUS and SMM. Participants will be randomly assigned, in equal numbers, to the PROFAST intervention or a healthy lifestyle education control for four months. The intervention is designed to promote a 14 hour nightly fast and will be delivered in the form of telephone-based health coaching and text-messaging. The overall objective of the research is to acquire preliminary outcome data suggesting the efficacy of the PROFAST intervention in in 1) improving body composition, and 2) altering clinical signs of disease progression to MM. As an exploratory objective, we will explore the impact of the PROFAST intervention on bone marrow adipose tissue (BMAT), which is a metabolically active adipose depot that resides near MM cells in the bone marrow. Upon completion, the proposed study will provide the preliminary foundation of evidence for a larger, more definitive trial.




Design and Rationale of Prolonged Nightly Fasting for Multiple Myeloma Prevention (PROFAST): Protocol for a Randomized Controlled Pilot Trial.
Authors: Lee D.J. , O'Donnell E.K. , Raje N. , Panaroni C. , Redd R. , Ligibel J. , Sears D.D. , Nadeem O. , Ghobrial I.M. , Marinac C.R. .
Source: JMIR research protocols, 2024-03-11; 13, p. e51368.
EPub date: 2024-03-11.
PMID: 38466984
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