NCT05565638Completed
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 · Last updated 7 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 22 Sept 2022
- Start date
- 6 Mar 2023
- Primary completion date
- 4 Aug 2025
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Obesity, Multiple myeloma
- NCT number
- NCT05565638
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From 6 Mar 2023 to the primary completion date, 4 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Diagnosis of overt MM or WM
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
Related publications
- Design and Rationale of Prolonged Nightly Fasting for Multiple Myeloma Prevention (PROFAST): Protocol for a Randomized Controlled Pilot Trial.JMIR Res Protoc · 2024 · PMID 38466984
This page is information, not medical advice. Discuss any trial with your doctor.