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PROFAST Intervention in Precursor Multiple Myeloma

NCT05565638 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-09-25

No results posted yet for this study

Summary

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

Conditions

Interventions

BEHAVIORAL

Prolonged Fasting Intervention

promote a 14-hour fast during the nighttime hours

BEHAVIORAL

EDUCATION CONTROL

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

Sponsors & Collaborators

Principal Investigators

  • Catherine Marinac, Ph.D · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2025-08-04
Completion
2025-08-04

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05565638 on ClinicalTrials.gov