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Fasting for Multiple Myeloma Prevention (PROFAST Trial)

N/A

Recruiting

Led By Catherine Marinac, Ph.D

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4-months

Awards & highlights

PROFAST Trial Summary

This trial will test whether a prolonged nightly fasting intervention can prevent overweight and obese individuals with blood cancer from developing the disease.

Who is the study for?

This trial is for overweight or obese adults with precursor blood cancers like MGUS, SMM, or SWM who fast less than 14 hours at night. Participants must be comfortable using a cell phone to send texts and have no active cancer treatments, diabetes without doctor's consent, night shift work, eating disorders affecting nighttime eating, or use of weight loss meds.Check my eligibility

What is being tested?

The study tests if not eating for extended periods at night (PROFAST) can help prevent blood cancer in individuals at risk. It randomly assigns participants to either the PROFAST group that practices prolonged fasting nightly for four months or a control group that follows a healthy lifestyle without specific fasting instructions.See study design

What are the potential side effects?

Potential side effects are not specified but may include hunger pangs, irritability due to fasting, potential hypoglycemia especially in those predisposed (like diabetics), and possible changes in sleep patterns.

PROFAST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

PROFAST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in body composition

Secondary outcome measures

(M-)protein concentrations/light chains change by mass spectrometry

Bone Marrow

Mass Spectrometry

+1 more

PROFAST Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PROLONGED FASTING INTERVENTIONExperimental Treatment1 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.

Group II: EDUCATION CONTROLActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,940 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,814 Total Patients Enrolled

3 Trials studying Cancer Prevention

1,233 Patients Enrolled for Cancer Prevention

Catherine Marinac, Ph.DPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Prolonged Fasting Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05565638 — N/A

Cancer Prevention Research Study Groups: PROLONGED FASTING INTERVENTION, EDUCATION CONTROL

Cancer Prevention Clinical Trial 2023: Prolonged Fasting Intervention Highlights & Side Effects. Trial Name: NCT05565638 — N/A

Prolonged Fasting Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05565638 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new participants still join this research endeavor?

"According to the clinicaltrials.gov database, this clinical trial has concluded its recruitment phase and is not presently accepting new participants. The study was first posted on November 1st 2022, with October 3rd representing its last update date. As an alternative, there are 1117 other trials actively recruiting patients at present time."

Answered by AI

Who else is applying?

What state do they live in?

South Carolina

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What site did they apply to?

Dana Farber Cancer Institute

How many prior treatments have patients received?

Why did patients apply to this trial?

I am 71, have been on a 3 year journey trying to lose 10 lbs. I went to New England Baptist of June 2020 to have a hip replacement done. I went in weighing 116 lbs. The next day after surgery until now I weigh 126 lbs. I have tried every diet, exercise plan you can name, but cannot lose those 10 lbs.!

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

PROFAST Intervention in Precursor Multiple Myeloma

Catherine Marinac, PhD 2023. "PROFAST Intervention in Precursor Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05565638.

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