PROFAST Intervention in Precursor Multiple Myeloma (PROFAST)
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| ClinicalTrials.gov Identifier: NCT05565638 |
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Recruitment Status :
Recruiting
First Posted : October 4, 2022
Last Update Posted : April 16, 2024
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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 | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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) |
| Actual Study Start Date : | March 6, 2023 |
| Estimated Primary Completion Date : | July 31, 2024 |
| Estimated Study Completion Date : | January 1, 2025 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: Prolonged Fasting Intervention
promote a 14-hour fast during the nighttime hours |
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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
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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 |
- Changes in body composition [ Time Frame: baseline to 4-months ]assessed via whole body DXA scans
- M-Protein change by Serum Protein Electrophoresis and Serum Free Light Chain assay [ Time Frame: 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 [ Time Frame: Baseline to 4-months ]
- Changes in bone marrow adiposity [ Time Frame: Baseline to 4-months ]
- Changes in plasma metabolites measured by liquid chromatography-mass spectrometry [ Time Frame: Baseline to 4-months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05565638
| Contact: Catherine Marinac, Ph.D | 617-632-4703 | CatherineR_Marinac@dfci.harvard.edu |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Catherine Marinac, PhD 617-632-4703 CatherineR_Marinac@dfci.harvard.edu | |
| Principal Investigator: Catherine Marinac, PhD | |
| Principal Investigator: | Catherine Marinac, Ph.D | Dana-Farber Cancer Institute |
| Responsible Party: | Catherine Marinac, PhD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT05565638 |
| Other Study ID Numbers: |
22-071 R21CA256644-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 4, 2022 Key Record Dates |
| Last Update Posted: | April 16, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Data can be shared no earlier than 1 year following the date of publication |
| Access Criteria: | DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cancer prevention Weight loss Smoldering Waldenstrom Macroglobulinemia(WM) MGUS |
Smoldering Multiple Myeloma Prolonged nightly fasting Multiple Myeloma |
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Multiple Myeloma Neoplasms, Plasma Cell Waldenstrom Macroglobulinemia Weight Loss Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Body Weight Changes Body Weight Lymphatic Diseases |