Fasting for Multiple Myeloma Prevention

(PROFAST Trial)

Overseen By Catherine Marinac, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Weight loss medication

Disqualifiers: Overt MM, WM, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a prolonged nightly fasting routine can help prevent certain types of blood cancer in individuals who are overweight or obese. Participants will either follow a fasting plan, gradually extending their nighttime fasting to 14 hours (Prolonged Fasting Intervention), or receive healthy lifestyle tips (Education Control). The trial targets individuals with conditions like MGUS, smoldering multiple myeloma, or smoldering Waldenstrom macroglobulinemia, who do not currently fast for 14 hours or more each night. Participants should be comfortable using text messages to record meal times and receive feedback. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new preventive strategies for blood cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this fasting intervention is safe for participants?

Research has shown that longer fasting periods, like the one in this study, are usually well-tolerated. Similar fasting routines have been tested in overweight or obese individuals, and serious side effects are uncommon. Most participants adapt to the fasting schedule, which gradually increases to a 14-hour fast each night. Some may experience hunger or fatigue, but these effects are typically temporary and manageable. This fasting method is also under study for its potential to lower risks related to blood cancer. However, specific safety data for this trial are not yet available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the prolonged fasting intervention for multiple myeloma prevention because it explores a non-invasive approach that could complement or provide an alternative to traditional treatments, which typically involve chemotherapy, radiation, or stem cell transplants. This intervention is unique because it leverages the body's natural fasting state, aiming to reduce risk factors associated with the development of multiple myeloma through lifestyle changes rather than pharmaceuticals. By encouraging participants to gradually adopt a 14-hour nightly fast, the approach may help modulate metabolic processes linked to cancer prevention, offering a potentially safer and more holistic method to reduce disease risk.

What evidence suggests that prolonged fasting might be an effective prevention strategy for blood cancer?

This trial will compare a Prolonged Fasting Intervention with an Education Control group to assess their effects on multiple myeloma prevention. Research suggests that longer nighttime fasting might help prevent blood cancers like multiple myeloma. Early studies show that fasting can improve body health and reduce substances often elevated in individuals with certain cancers. By fasting for several hours at night, the body may have more time to heal, potentially lowering cancer risk. Some evidence also indicates that this method might aid in weight loss and boost overall health. While more research is needed, initial results are promising for using prolonged fasting as a prevention strategy. ^{1 2 3 4 6}

Who Is on the Research Team?

Catherine Marinac, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My diagnosis is MGUS, Smoldering MM, or Smoldering WM, confirmed by medical records.

Ability to understand and the willingness to sign a written informed consent document

You have a cell phone and can send and receive text messages easily.

Exclusion Criteria

I don't have conditions that would prevent me from fasting at night or participating fully in the trial.

I have been diagnosed with multiple myeloma or Waldenström's macroglobulinemia.

I am currently being treated for another type of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into either the PROFAST intervention group or the Healthy Lifestyle Control group for 4 months

16 weeks

Weekly virtual check-ins with health coach and text messaging support

Follow-up

Participants are monitored for changes in body composition and M-Protein levels

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EDUCATION CONTROL
• Prolonged Fasting Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: PROLONGED FASTING INTERVENTION Experimental Treatment 1 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 CONTROL Active Control 1 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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study of 139 breast cancer patients during Ramadan found that fasting did not negatively affect adherence to oral hormonal therapies, with adherence rates of 94.2% during Ramadan and 95.7% in the month prior.

Factors such as previous non-adherence and shorter duration of hormonal therapy were significant predictors of non-adherence during Ramadan, while fasting and other demographic factors did not influence treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does fasting during Ramadan trigger non-adherence to oral hormonal therapy in breast cancer patients? Zeeneldin, AA., Gaber, AA., Taha, FM.[2020]

Fasting may serve as a promising anticancer strategy by enhancing the survival of normal cells while potentially killing cancer cells, supported by nonclinical evidence showing it can reduce chemotherapy toxicity and improve its effectiveness.

Current clinical research on fasting as an adjunct to chemotherapy is encouraging but still in early stages, highlighting the need for personalized approaches and further studies to establish safety and efficacy through large randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Far Are We from Prescribing Fasting as Anticancer Medicine? Deligiorgi, MV., Liapi, C., Trafalis, DT.[2021]

The 5-day Fasting-Mimicking Diet (FMD) was found to be safe and feasible for cancer patients undergoing treatment, with only mild side effects reported during the study involving 90 participants.

FMD led to beneficial changes in body composition, including reduced fat mass and stable weight, while also decreasing levels of insulin and growth factors like IGF1 and leptin, suggesting potential metabolic benefits alongside cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment. Valdemarin, F., Caffa, I., Persia, A., et al.[2021]

In a phase II study involving 129 patients with HER2-negative breast cancer, a fasting mimicking diet (FMD) improved patients' perceptions of chemotherapy side effects and overall quality of life compared to a regular diet.

Patients adhering to the FMD reported better emotional, physical, and social functioning, along with lower levels of fatigue, nausea, and insomnia, suggesting that FMD may enhance the supportive care during neoadjuvant chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT (BOOG 2013-14) trial. Lugtenberg, RT., de Groot, S., Kaptein, AA., et al.[2021]

Fasting or a fasting-mimicking diet (FMD) can slow down tumor growth but does not enhance the sensitivity of colorectal cancer (CRC) cells to chemotherapy drugs like 5-fluorouracil and oxaliplatin, indicating a complex relationship between fasting and cancer treatment.

The study identified that fasting induces CRC cells to enter a slow-cycling state, which may lead to the development of drug-tolerant persister cells that contribute to cancer relapse; however, combining fasting with ferroptosis inducers could enhance tumor inhibition and target these resistant cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells. Liu, X., Peng, S., Tang, G., et al.[2023]

Periodic fasting enhances the effectiveness of endocrine treatments for hormone receptor-positive breast cancer by increasing their anti-cancer activity.

Fasting may help delay the development of resistance to these treatments by lowering levels of blood leptin, insulin, and insulin-like growth factor 1 (IGF1), suggesting a potential new strategy for improving breast cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing endocrine therapy activity via fasting cycles: biological rationale and clinical feasibility. Caffa, I., Nencioni, A.[2021]

Peri-chemotherapy fasting is considered safe for well-nourished cancer patients undergoing short-term chemotherapy, with good patient compliance and only mild weight loss reported.

While some studies suggest potential benefits, such as improved tumor response in breast cancer, claims of significant oncological advantages from fasting during chemotherapy are currently premature and not well-supported by clinical data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calorie restriction in cancer patients undergoing chemotherapy: Facts, phantasy or misunderstanding. Bozzetti, F.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964146/

Design and Rationale of Prolonged Nightly Fasting for ... PROFAST is a pilot randomized controlled trial of our 4-month prolonged nightly fasting intervention in patients with overweight or obesity with MGUS, SMM, or ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38466984/

Design and Rationale of Prolonged Nightly Fasting ... - PubMed We aim to investigate the effects of 4-month prolonged nightly fasting on body composition and tumor biomarkers among individuals with overweight or obesity.

3. trialx.com trialx.com/clinical-trials/listings/244200/profast-intervention-in-precursor-multiple-myeloma/

PROFAST Intervention in Precursor Multiple Myeloma This is a 4-month randomized trial of a prolonged nightly fasting intervention (PROFAST) in 40 overweight and obese individuals with monoclonal ...

4. dana-farber.org dana-farber.org/clinical-trials/22-071

PROlonged Nightly FASTing for Obesity Reduction and ... This is a 4-month randomized trial of a prolonged nightly fasting intervention (PROFAST) in 40 overweight and obese individuals with monoclonal gammopathy ...

5. researchgate.net researchgate.net/publication/375879905_Prolonged_nightly_fasting_for_multiple_myeloma_prevention_PROFAST_design_and_rationale_of_a_randomized_controlled_pilot_trial_Preprint

(PDF) Prolonged nightly fasting for multiple myeloma ... ... MGUS, SMM, or SWM. The goal. of the trial is to acquire preliminary outcome data for the. efficacy of prolonged nightly fasting on body composition and.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05565638/profast-intervention-in-precursor-multiple-myeloma

PROFAST Intervention in Precursor Multiple Myeloma The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants ...