Prolonged nightly fasting intervention for preventing blood cancer in overweight individuals
PROlonged Nightly FASTing for Obesity Reduction and Prevention of Disease Prevention in Precursor Multiple Myeloma (PROFAST)
This study tests if a new nightly fasting plan can help overweight people with certain blood conditions avoid developing blood cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05565638 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a prolonged nightly fasting intervention (PROFAST) over four months in overweight and obese individuals diagnosed with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and smoldering waldenstrom macroglobulinemia (SWM). Participants will be randomly assigned to either the PROFAST intervention group, which involves gradually increasing fasting hours, or a healthy lifestyle control group. The study aims to determine if this fasting strategy can improve body composition and potentially prevent the progression to blood cancer. Participants will receive support through health coaching and a text messaging platform to track their meal timings.
Who should consider this trial
Good fit: Ideal candidates include overweight or obese adults aged 18 and older with a documented diagnosis of MGUS, SMM, or SWM.
Not a fit: Patients with overt multiple myeloma or other malignancies requiring active therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel approach to prevent the development of blood cancer in at-risk overweight individuals.
How similar studies have performed: While fasting interventions have been explored in various contexts, this specific approach targeting blood cancer prevention in this patient population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Catherine Marinac, Ph.D — Dana-Farber Cancer Institute
- Study coordinator: Catherine Marinac, Ph.D
- Email: CatherineR_Marinac@dfci.harvard.edu
- Phone: 617-632-4703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.