COMPLETED

PROFAST Intervention in Precursor Multiple Myeloma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2023-04-20
Study Completion:2025-08-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05565638

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * BMI \>= 25 kg/m2
  2. * 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.
  3. * At least 18 years of age
  4. * Currently fasting for \<14 hours per night, as assessed using 24-hour food recalls
  5. * Owns a cell phone and is comfortable sending and receiving text messages
  6. * Ability to understand and the willingness to sign a written informed consent document
  1. * Diagnosis of overt MM or WM
  2. * Patients diagnosed with another malignancy requiring active therapy
  3. * 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.
  4. * 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

Contacts and Locations

Principal Investigator

Catherine Marinac, Ph.D
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Catherine Marinac, Ph.D, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-20
Study Completion Date2025-08-04

Study Record Updates

Study Start Date2023-04-20
Study Completion Date2025-08-04

Terms related to this study

Keywords Provided by Researchers

  • Cancer prevention
  • Weight loss
  • Smoldering Waldenstrom Macroglobulinemia(WM)
  • MGUS
  • Smoldering Multiple Myeloma
  • Prolonged nightly fasting
  • Multiple Myeloma

Additional Relevant MeSH Terms

  • Cancer Prevention
  • Weight Loss
  • Smoldering Waldenstrom Macroglobulinemia(WM)
  • MGUS
  • Fasting
  • Multiple Myeloma