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

ENROLLING
Protocol # :
22-071
Conditions
Cancer Prevention
Weight Loss
Smoldering Waldenstrom Macroglobulinemia(WM)
MGUS
Fasting
Multiple Myeloma
Phase
Feasibility / Pilot
Disease Sites
Multiple Myeloma
Principal Investigator
Marinac, Catherine, Rose

Trial Description

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

Eligibility Requirements

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

22-071