PROFAST Intervention in Precursor Multiple Myeloma
PROFAST
PROlonged Nightly FASTing for Obesity Reduction and Prevention of Disease Prevention in Precursor Multiple Myeloma (PROFAST)
2 other identifiers
interventional
23
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2022
CompletedFirst Posted
Study publicly available on registry
October 4, 2022
CompletedStudy Start
First participant enrolled
March 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2025
CompletedSeptember 25, 2025
September 1, 2025
2.4 years
September 22, 2022
September 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in body composition
assessed via whole body DXA scans
baseline to 4-months
Secondary Outcomes (4)
M-Protein change by Serum Protein Electrophoresis and Serum Free Light Chain assay
baseline to 4-months
(M-)protein concentrations/light chains change by mass spectrometry
Baseline to 4-months
Changes in bone marrow adiposity
Baseline to 4-months
Changes in plasma metabolites measured by liquid chromatography-mass spectrometry
Baseline to 4-months
Study Arms (2)
PROLONGED FASTING INTERVENTION
EXPERIMENTALThe 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.
EDUCATION CONTROL
ACTIVE COMPARATORFor 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
Interventions
promote a 14-hour fast during the nighttime hours
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
Eligibility Criteria
You may qualify if:
- BMI \>= 25 kg/m2
- Documented diagnosis of MGUS or Smoldering MM(SMM) or Smoldering Waldenstrom Macroglobulinemia(WM) via EMR review. \*note: please review case with PI or treating MD if diagnosis is uncertain.
- At least 18 years of age
- Currently fasting for \<14 hours per night, as assessed using 24-hour food recalls
- Owns a cell phone and is comfortable sending and receiving text messages
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- Diagnosis of overt MM or WM
- Patients diagnosed with another malignancy requiring active therapy
- Clinical diagnosis of diabetes, which may increase the risk of hypoglycemia with a prolonged fast. Note: patients with diabetes may enroll with consent from MD that manages their clinical care.
- Any other condition that, in the investigator's judgment, would contraindicate prolonged nightly fasting or otherwise interfere with participation in the trial, including night shift work, night eating syndrome, taking weight loss medication, or participation in another weight loss program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
Lee DJ, O'Donnell EK, Raje N, Panaroni C, Redd R, Ligibel J, Sears DD, Nadeem O, Ghobrial IM, Marinac CR. Design and Rationale of Prolonged Nightly Fasting for Multiple Myeloma Prevention (PROFAST): Protocol for a Randomized Controlled Pilot Trial. JMIR Res Protoc. 2024 Mar 11;13:e51368. doi: 10.2196/51368.
PMID: 38466984DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Marinac, Ph.D
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 22, 2022
First Posted
October 4, 2022
Study Start
March 6, 2023
Primary Completion
August 4, 2025
Study Completion
August 4, 2025
Last Updated
September 25, 2025
Record last verified: 2025-09