Clinical trial · Interventional
PROFAST Intervention in Precursor Multiple Myeloma
PROlonged Nightly FASTing for Obesity Reduction and Prevention of Disease Prevention in Precursor Multiple Myeloma (PROFAST)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Prevention | — | UNRESOLVED | — |
| Fasting | — | UNRESOLVED | — |
| MGUS | Monoclonal Gammopathy of Undetermined Significance | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Smoldering Waldenstrom Macroglobulinemia(WM) | Smoldering Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.85 |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EDUCATION CONTROL | Behavioral | — | UNRESOLVED |
| Prolonged Fasting Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PROLONGED FASTING INTERVENTION
- description
- 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.
- interventionNames
- Behavioral: Prolonged Fasting Intervention
- type
- ACTIVE_COMPARATOR
- label
- EDUCATION CONTROL
- description
- 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
- interventionNames
- Behavioral: EDUCATION CONTROL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDLee 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 38466984