40 Participants Needed

Fasting for Multiple Myeloma Prevention

(PROFAST Trial)

CM
CM
Overseen ByCatherine Marinac, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests if not eating for a certain number of hours each night can help overweight and obese people with certain pre-cancerous conditions avoid developing blood cancer. The study involves a small group of people who will either follow the fasting plan or receive healthy living tips. Not eating for a set period each night is a new approach for weight loss that may have additional health benefits.

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 data supports the effectiveness of the fasting treatment for multiple myeloma prevention?

Research suggests that fasting can enhance the effectiveness of cancer treatments by reducing harmful side effects and improving treatment outcomes. Studies have shown that fasting or fasting-mimicking diets can lower levels of certain growth factors and hormones that cancer cells need to grow, potentially making treatments more effective.12345

How is the Prolonged Fasting Intervention treatment different from other treatments for multiple myeloma?

The Prolonged Fasting Intervention is unique because it uses fasting to potentially protect normal cells while targeting cancer cells, unlike traditional treatments that often involve drugs or chemotherapy. This approach is still being researched, but it may help reduce the side effects of other cancer treatments and improve their effectiveness.24567

Research Team

CM

Catherine Marinac, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.
See 2 more

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
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

Find a Clinic Near You

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+

Findings from Research

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.
Enhancing endocrine therapy activity via fasting cycles: biological rationale and clinical feasibility.Caffa, I., Nencioni, A.[2021]
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.
How Far Are We from Prescribing Fasting as Anticancer Medicine?Deligiorgi, MV., Liapi, C., Trafalis, DT.[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.
Calorie restriction in cancer patients undergoing chemotherapy: Facts, phantasy or misunderstanding.Bozzetti, F.[2022]

References

Enhancing endocrine therapy activity via fasting cycles: biological rationale and clinical feasibility. [2021]
How Far Are We from Prescribing Fasting as Anticancer Medicine? [2021]
Calorie restriction in cancer patients undergoing chemotherapy: Facts, phantasy or misunderstanding. [2022]
Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells. [2023]
Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment. [2021]
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. [2021]
Does fasting during Ramadan trigger non-adherence to oral hormonal therapy in breast cancer patients? [2020]