PROFAST Intervention in Precursor Multiple Myeloma

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05565638

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer Prevention Weight Loss Smoldering Waldenstrom Macroglobulinemia(WM) MGUS Fasting Multiple Myeloma	Behavioral: Prolonged Fasting Intervention Behavioral: EDUCATION CONTROL	N/A

Detailed Description

The purpose of this research study is to learn if fasting for a prolonged period of time could be used in the future to help improve body composition and prevent blood cancer in overweight and obese individuals with MGUS, SMM, and SWM. Multiple myeloma is a cancer of the plasma cells, which is an important part of the immune system. Participants with active multiple myeloma generally require treatment. There are currently no approved therapies or prevention strategies for smoldering multiple myeloma or monoclonal gammopathy of undetermined significance.

The National Cancer Institute of the National Institutes of Health is supporting this research study by providing funding.

This research study is a 4-month randomized trial of prolonged nightly fasting (PROFAST). It is expected that about 40 people will take part in this research study. The total study duration is 4 months.

Participants in the study will be randomized, in equal numbers to either the nightly fasting intervention group or a control group.

The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times via the text messaging system. The text messaging system will be used throughout the duration of the study.
For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PROLONGED FASTING INTERVENTION The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times they record via the text messaging system. The text messaging system will be used throughout the duration of the study.	Behavioral: Prolonged Fasting Intervention promote a 14-hour fast during the nighttime hours
Active Comparator: EDUCATION CONTROL For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study	Behavioral: EDUCATION CONTROL introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living

Arm

Intervention/Treatment

Experimental: PROLONGED FASTING INTERVENTION

The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times they record via the text messaging system. The text messaging system will be used throughout the duration of the study.

Behavioral: Prolonged Fasting Intervention

promote a 14-hour fast during the nighttime hours

Active Comparator: EDUCATION CONTROL

For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study

Behavioral: EDUCATION CONTROL

introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living

Outcome Measures

Primary Outcome Measures

Changes in body composition [baseline to 4-months]
assessed via whole body DXA scans

Secondary Outcome Measures

M-Protein change by Serum Protein Electrophoresis and Serum Free Light Chain assay [baseline to 4-months]
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.
(M-)protein concentrations/light chains change by mass spectrometry [Baseline to 4-months]
Changes in bone marrow adiposity [Baseline to 4-months]
Changes in plasma metabolites measured by liquid chromatography-mass spectrometry [Baseline to 4-months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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