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Cancer PreventionPROFASTNCT05565638

PROFAST Intervention in Precursor Multiple Myeloma

A study testing Prolonged Fasting Intervention in people with Cancer Prevention and Weight Loss, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prolonged Fasting Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
6 Mar 2023to 4 Aug 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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

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
Read the detailed description

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.
Being tested
Prolonged Fasting Intervention, EDUCATION CONTROL
Keywords
Cancer prevention, Weight loss, Smoldering Waldenstrom Macroglobulinemia(WM), MGUS, Smoldering Multiple Myeloma, Prolonged nightly fasting, Multiple Myeloma
Medical subject headings
Weight Loss, Fasting, Multiple Myeloma, Smoldering Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolonged Fasting InterventionBehavioural

    promote a 14-hour fast during the nighttime hours

  • EDUCATION CONTROLBehavioural

    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

Study groups in NCT05565638
Study groupRoleWhat they receive
PROLONGED FASTING INTERVENTIONExperimentalThe 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.
Receives: Behavioral: Prolonged Fasting Intervention
EDUCATION CONTROLActive 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
Receives: Behavioral: EDUCATION CONTROL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Body Composition (% Body Fat)

    assessed via whole body DXA scans

    Measured: baseline to 4-months

Secondary outcomes (4)

  1. M-Protein Change by Serum Protein Electrophoresis and Serum Free Light Chain Assay

    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.

    Measured: baseline to 4-months

  2. (M-)Protein Concentrations/Light Chains Change by Mass Spectrometry

    Measured: Baseline to 4-months

  3. Changes in Bone Marrow Adiposity

    Measured: Baseline to 4-months

  4. Changes in Plasma Metabolites Measured by Liquid Chromatography-mass Spectrometry

    Measured: Baseline to 4-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start6 Mar 2023
  3. Primary completion4 Aug 2025
  4. Study completion4 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05565638
Sponsor's protocol ID
22-071
Other IDs
R21CA256644-01A1
Acronym
PROFAST
Status last verified
Sep 2026
First submitted
22 Sep 2022
Last updated
7 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38466984

Questions about this trial

What is this clinical trial studying?

A study testing Prolonged Fasting Intervention in people with Cancer Prevention and Weight Loss, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Body Composition (% Body Fat) (time frame: baseline to 4-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05565638, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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