Evidence map›Paper›PMID 38466984›Full record

ArticleJMIR research protocols2024

Design and Rationale of Prolonged Nightly Fasting for Multiple Myeloma Prevention (PROFAST): Protocol for a Randomized Controlled Pilot Trial.

David J Lee, Elizabeth K O'Donnell, Noopur Raje, Cristina Panaroni, Robert Redd, Jennifer Ligibel, Dorothy D Sears, Omar Nadeem, Irene M Ghobrial, Catherine R Marinac

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05565638 (PROlonged Nightly FASTing for Obesity Reduction and Prevention of Disease Prevention in Precursor Multiple Myeloma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05565638 nacompletednot on this map

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

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2023 to 2025Enrolled23ConditionsCancer Prevention, Weight Loss, Smoldering Waldenstrom Macroglobulinemia(WM), MGUSArmsProlonged Fasting Intervention, EDUCATION CONTROL
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

David J LeeDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United States.ORCID https://orcid.org/0000-0002-0330-1824
Elizabeth K O'DonnellDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.ORCID https://orcid.org/0000-0002-4042-1526
Noopur RajeDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United States.ORCID https://orcid.org/0000-0003-3066-1275
Cristina PanaroniDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United States.ORCID https://orcid.org/0009-0007-4724-3260
Robert ReddBiostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, United States.ORCID https://orcid.org/0000-0002-1329-5288
Jennifer LigibelDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.ORCID https://orcid.org/0000-0002-0633-3151
Dorothy D SearsCollege of Health Solutions, Arizona State University, Phoenix, AZ, United States.ORCID https://orcid.org/0000-0002-9260-3540
Omar NadeemDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.ORCID https://orcid.org/0000-0002-4124-4277
Irene M GhobrialDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.ORCID https://orcid.org/0000-0001-7361-3092
Catherine R MarinacDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.ORCID https://orcid.org/0000-0002-9128-3012
Harvard University · USArizona State University · USDana-Farber Cancer Institute · US

Funding

Pathways to Mentorship and Research: Training the Next Generation Physician-ScientistsR25AI147393 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI VYAS, JATIN M · 2019 to 2024
$1.8M
MGH Next Generation Physician-Scientist Through Stimulating Access to Research in Residency Program (MGH-Next Gen StARR)R38HL150212 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI VYAS, JATIN M · 2020 to 2023
$1.3M
Repurposing Metformin for the Prevention of Disease Progression in Precursor Multiple MyelomaK22CA251648 · NCI · DANA-FARBER CANCER INST · PI MARINAC, CATHERINE · 2020 to 2022
$577k
Prolonged Nightly Fasting as a Behavioral Intervention for Obesity Reduction and the Prevention of Progression in Precursor Multiple MyelomaR21CA256644 · NCI · DANA-FARBER CANCER INST · PI MARINAC, CATHERINE · 2022 to 2023
$453k
NCI NIH HHS K22 CA251648NCI NIH HHS R21 CA256644NHLBI NIH HHS R38 HL150212NIAID NIH HHS R25 AI147393
6 · The paper itself

Abstract

backgroundObesity is an established, modifiable risk factor of multiple myeloma (MM); yet, no lifestyle interventions are routinely recommended for patients with overweight or obesity with MM precursor conditions. Prolonged nightly fasting is a simple, practical dietary regimen supported by research, suggesting that the synchronization of feeding-fasting timing with sleep-wake cycles favorably affects metabolic pathways implicated in MM. We describe the design and rationale of a randomized controlled pilot trial evaluating the efficacy of a regular, prolonged nighttime fasting schedule among individuals with overweight or obesity at high risk for developing MM or a related lymphoid malignancy.

objectiveWe aim to investigate the effects of 4-month prolonged nightly fasting on body composition and tumor biomarkers among individuals with overweight or obesity with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or smoldering Waldenström macroglobulinemia (SWM).

methodsIndividuals with MGUS, SMM, or SWM aged ≥18 years and a BMI of ≥25 kg/m

resultsThe PROlonged nightly FASTing (PROFAST) study was funded in June 2022. Participant recruitment commenced in April 2023. As of July 2023, six participants consented to the study. The study is expected to be completed by April 2024, and data analysis and results are expected to be published in the first quarter of 2025.

conclusionsPROFAST serves as an important first step in exploring the premise that prolonged nightly fasting is a strategy to control obesity and obesity-related mechanisms of myelomagenesis. In evaluating the feasibility and impact of prolonged nightly fasting on body composition, bone marrow adipose tissue, and biomarkers of tumor burden, this pilot study may generate hypotheses regarding metabolic mechanisms underlying MM development and ultimately inform clinical and public health strategies for MM prevention.

trial registrationClinicalTrials.gov NCT05565638; http://clinicaltrials.gov/ct2/show/NCT05565638. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51368.

Indexed as

bloodBMIbody mass indexcancercancer preventioncontrolled trialcontrolled trialsdietdietaryeatingfastinggammopathyhematologicalhematologyintermittent fastingMGUSmyelomaobeseobesityoncologicaloncologyoverweightrandomizedRCTsmoldering myelomatumortumorsweight

Identifiers

PMID38466984
PMCPMC10964146
OpenAlexW4388942578

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.