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PROFAST Intervention in Precursor Multiple Myeloma (PROFAST)

Primary Purpose

Cancer Prevention, Weight Loss, Smoldering Waldenstrom Macroglobulinemia(WM)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Fasting Intervention
EDUCATION CONTROL
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Prevention focused on measuring Cancer prevention, Weight loss, Smoldering Waldenstrom Macroglobulinemia(WM), MGUS, Smoldering Multiple Myeloma, Prolonged nightly fasting, Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PROLONGED FASTING INTERVENTION

EDUCATION CONTROL

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Changes in body composition
assessed via whole body DXA scans

Secondary Outcome Measures

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.
(M-)protein concentrations/light chains change by mass spectrometry
Changes in bone marrow adiposity
Changes in plasma metabolites measured by liquid chromatography-mass spectrometry

Full Information

First Posted
September 22, 2022
Last Updated
March 27, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05565638
Brief Title
PROFAST Intervention in Precursor Multiple Myeloma
Acronym
PROFAST
Official Title
PROlonged Nightly FASTing for Obesity Reduction and Prevention of Disease Prevention in Precursor Multiple Myeloma (PROFAST)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Prevention, Weight Loss, Smoldering Waldenstrom Macroglobulinemia(WM), MGUS, Fasting, Multiple Myeloma
Keywords
Cancer prevention, Weight loss, Smoldering Waldenstrom Macroglobulinemia(WM), MGUS, Smoldering Multiple Myeloma, Prolonged nightly fasting, Multiple Myeloma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PROLONGED FASTING INTERVENTION
Arm Type
Experimental
Arm Description
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.
Arm Title
EDUCATION CONTROL
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Fasting Intervention
Intervention Description
promote a 14-hour fast during the nighttime hours
Intervention Type
Behavioral
Intervention Name(s)
EDUCATION CONTROL
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in body composition
Description
assessed via whole body DXA scans
Time Frame
baseline to 4-months
Secondary Outcome Measure Information:
Title
M-Protein change by Serum Protein Electrophoresis and Serum Free Light Chain assay
Description
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.
Time Frame
baseline to 4-months
Title
(M-)protein concentrations/light chains change by mass spectrometry
Time Frame
Baseline to 4-months
Title
Changes in bone marrow adiposity
Time Frame
Baseline to 4-months
Title
Changes in plasma metabolites measured by liquid chromatography-mass spectrometry
Time Frame
Baseline to 4-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Marinac, Ph.D
Phone
617-632-4703
Email
CatherineR_Marinac@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Marinac, Ph.D
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Marinac, PhD
Phone
617-632-4703
Email
CatherineR_Marinac@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Catherine Marinac, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

PROFAST Intervention in Precursor Multiple Myeloma

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