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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 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common cancer prevention treatments often focus on dietary and lifestyle modifications that influence metabolic pathways. Prolonged nightly fasting, as studied in the PROFAST trial, aims to reduce cancer risk by improving insulin sensitivity and reducing hyperinsulinemia, which are linked to cancer progression. This fasting approach may also decrease oxidative stress and inflammation, both of which are associated with cancer development. Additionally, dietary fiber intake, reduced alcohol and tobacco use, and maintaining a healthy weight through balanced nutrition and physical activity are crucial. These interventions collectively help in modulating metabolic and hormonal environments, thereby reducing the risk of cancer recurrence and improving overall survival rates for cancer prevention patients.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,083 Previous Clinical Trials
341,691 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,742 Previous Clinical Trials
40,957,730 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
~2 spots leftby Jul 2024