Multiple Myeloma Clinical Trial
— PROFASTOfficial 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
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 1, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in body composition | assessed via whole body DXA scans | baseline to 4-months | |
Secondary | 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. | baseline to 4-months | |
Secondary | (M-)protein concentrations/light chains change by mass spectrometry | Baseline to 4-months | ||
Secondary | Changes in bone marrow adiposity | Baseline to 4-months | ||
Secondary | Changes in plasma metabolites measured by liquid chromatography-mass spectrometry | Baseline to 4-months |
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