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.
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
- Conditions the study is for
- Cancer Prevention, Weight Loss, Smoldering Waldenstrom Macroglobulinemia(WM)
- What is being tested?
- Prolonged Fasting Intervention
- Type of treatment
- Lifestyle or therapy programme
- 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
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
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.
- Conditions
- Cancer Prevention, Weight Loss, Smoldering Waldenstrom Macroglobulinemia(WM), MGUS, Fasting, Multiple Myeloma
- 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 group | Role | What they receive |
|---|---|---|
| PROLONGED FASTING INTERVENTION | Experimental | 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. Receives: Behavioral: Prolonged Fasting Intervention |
| EDUCATION CONTROL | Active comparator | 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 Receives: Behavioral: EDUCATION CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Composition (% Body Fat)
assessed via whole body DXA scans
Measured: baseline to 4-months
Secondary outcomes (4)
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
(M-)Protein Concentrations/Light Chains Change by Mass Spectrometry
Measured: Baseline to 4-months
Changes in Bone Marrow Adiposity
Measured: Baseline to 4-months
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.
- First posted4 Oct 2022
- Study start6 Mar 2023
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PreventionStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Catherine Marinac, PhD, Dana-Farber Cancer Institute
- Investigators
- Catherine Marinac, Ph.D, Principal investigator, Dana-Farber Cancer Institute
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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