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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA256644-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROLONGED FASTING INTERVENTION | Experimental | 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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| EDUCATION CONTROL | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Fasting Intervention | Behavioral | promote a 14-hour fast during the nighttime hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in body composition | assessed via whole body DXA scans | baseline to 4-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Marinac, Ph.D | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38466984 | Derived | Lee DJ, O'Donnell EK, Raje N, Panaroni C, Redd R, Ligibel J, Sears DD, Nadeem O, Ghobrial IM, Marinac CR. Design and Rationale of Prolonged Nightly Fasting for Multiple Myeloma Prevention (PROFAST): Protocol for a Randomized Controlled Pilot Trial. JMIR Res Protoc. 2024 Mar 11;13:e51368. doi: 10.2196/51368. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D005215 | Fasting |
| D009101 | Multiple Myeloma |
| D000075122 | Smoldering Multiple Myeloma |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| EDUCATION CONTROL | Behavioral | 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 |
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| (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 |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011230 | Precancerous Conditions |
| D006942 | Hypergammaglobulinemia |