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.
Is the Prolonged Fasting Intervention a promising treatment for preventing multiple myeloma?Yes, the Prolonged Fasting Intervention is promising because fasting can help protect normal cells while targeting cancer cells. It may also enhance the effectiveness of chemotherapy and reduce its side effects. Early studies show that fasting can be safely combined with cancer treatments, and it might improve patients' quality of life.367912
What safety data exists for fasting as a treatment for multiple myeloma prevention?The provided research does not contain specific safety data for fasting interventions in multiple myeloma prevention. The studies focus on other treatments and strategies for multiple myeloma, such as inhibition of fatty acid metabolism, oral therapies, and bisphosphonates, but do not address fasting or its safety.124510
What data supports the idea that Fasting for Multiple Myeloma Prevention is an effective treatment?The available research shows that fasting can enhance the effects of cancer treatments by making cancer cells more sensitive to therapy while protecting normal cells. Studies have found that fasting can reduce the side effects of chemotherapy and improve its effectiveness. For example, a fasting-mimicking diet was shown to be safe and helped maintain patients' weight and strength while reducing fat mass and certain growth factors linked to cancer. Although more research is needed, these findings suggest that fasting could be a promising addition to cancer treatment.7891112
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you have diabetes, you may need consent from your doctor to participate.
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
I am 18 years old or older.
Exclusion Criteria
I have been diagnosed with multiple myeloma or Waldenström's macroglobulinemia.
I am currently being treated for another type of cancer.
Treatment Details
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.
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
Research locations nearbySelect from list below to view details:
Dana Farber Cancer InstituteBoston, MA
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma. [2019]A Phase I trial (NCT00109109) of oral vorinostat 200, 250 or 300 mg twice daily for 5 days/week/4-week cycle or 200, 300, or 400 mg twice daily for 14 days/3-week cycle until progressive disease or intolerable toxicity was conducted. Patients with measurable, relapsed/refractory multiple myeloma were eligible. The objectives were to determine maximum tolerated doses (MTDs) and assess activity and safety. Thirteen patients (median age, 63 years; median prior therapies, 3) were enrolled. MTDs were not determined due to early study termination by sponsor decision. One patient (250 mg twice daily 5 days/week) developed dose-limiting toxicity (DLT; grade 3 fatigue). There were no other DLTs and the maximum administered doses were 250 mg twice daily for 5 days/week/4-week cycle and 200 mg twice daily for 14 days/3-week cycle. Drug-related adverse experiences included fatigue, anorexia, dehydration, diarrhea, and nausea and were mostly grade
Effect of pamidronate 30 mg versus 90 mg on physical function in patients with newly diagnosed multiple myeloma (Nordic Myeloma Study Group): a double-blind, randomised controlled trial. [2018]Compared with placebo, prophylactic treatment with bisphosphonates reduces risk of skeletal events in patients with multiple myeloma. However, because of toxicity associated with long-term bisphosphonate treatment, establishing the lowest effective dose is important. This study compared the effect of two doses of pamidronate on health-related quality of life and skeletal morbidity in patients with newly diagnosed multiple myeloma.
Does fasting during Ramadan trigger non-adherence to oral hormonal therapy in breast cancer patients? [2020]To estimate the effect of fasting during Ramadan (the ninth lunar month) on adherence to oral hormonal therapies (OHT) among breast cancer (BC) patients.
Inhibition of fatty acid metabolism reduces human myeloma cells proliferation. [2021]Multiple myeloma is a haematological malignancy characterized by the clonal proliferation of plasma cells. It has been proposed that targeting cancer cell metabolism would provide a new selective anticancer therapeutic strategy. In this work, we tested the hypothesis that inhibition of β-oxidation and de novo fatty acid synthesis would reduce cell proliferation in human myeloma cells. We evaluated the effect of etomoxir and orlistat on fatty acid metabolism, glucose metabolism, cell cycle distribution, proliferation, cell death and expression of G1/S phase regulatory proteins in myeloma cells. Etomoxir and orlistat inhibited β-oxidation and de novo fatty acid synthesis respectively in myeloma cells, without altering significantly glucose metabolism. These effects were associated with reduced cell viability and cell cycle arrest in G0/G1. Specifically, etomoxir and orlistat reduced by 40-70% myeloma cells proliferation. The combination of etomoxir and orlistat resulted in an additive inhibitory effect on cell proliferation. Orlistat induced apoptosis and sensitized RPMI-8226 cells to apoptosis induction by bortezomib, whereas apoptosis was not altered by etomoxir. Finally, the inhibitory effect of both drugs on cell proliferation was associated with reduced p21 protein levels and phosphorylation levels of retinoblastoma protein. In conclusion, inhibition of fatty acid metabolism represents a potential therapeutic approach to treat human multiple myeloma.
Treating Multiple Myeloma Patients With Oral Therapies. [2022]Recent advances have highlighted the importance of long-term, continuous treatment in multiple myeloma (MM) to improve survival. However, treatment burden continues to negatively impact the real-world duration of MM therapy, and strategies to limit the adverse impact of treatment on patient quality of life are therefore particularly important. Oral MM therapies include the immunomodulatory drugs lenalidomide, thalidomide, and pomalidomide; the alkylating agents melphalan and cyclophosphamide; the histone deacetylase inhibitor panobinostat; the corticosteroids prednisone and dexamethasone; and the proteasome inhibitor ixazomib. The most commonly reported adverse events with these treatments include hematologic events such as thrombocytopenia and neutropenia; the gastrointestinal events nausea, vomiting, and diarrhea; venous thrombotic events such as deep-vein thrombosis and pulmonary embolism; and events such as rash and peripheral neuropathy. It is important that patients receiving oral therapies at home report symptoms before they become difficult to manage. Appropriate management of these treatment-related adverse events, awareness of both food and drug interactions, and assisting patients with out-of-pocket costs are all important factors in providing efficacious, sustainable, and convenient MM therapy. We outline evidence-based recommendations to provide a practical guide for health care providers addressing the effective management of MM patients receiving oral therapy.
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]In the phase II DIRECT study a fasting mimicking diet (FMD) improved the clinical response to neoadjuvant chemotherapy as compared to a regular diet. Quality of Life (QoL) and illness perceptions regarding the possible side effects of chemotherapy and the FMD were secondary outcomes of the trial.
How Far Are We from Prescribing Fasting as Anticancer Medicine? [2021](1) Background: the present review provides a comprehensive and up-to date overview of the potential exploitation of fasting as an anticancer strategy. The rationale for this concept is that fasting elicits a differential stress response in the setting of unfavorable conditions, empowering the survival of normal cells, while killing cancer cells. (2) Methods: the present narrative review presents the basic aspects of the hormonal, molecular, and cellular response to fasting, focusing on the interrelationship of fasting with oxidative stress. It also presents nonclinical and clinical evidence concerning the implementation of fasting as adjuvant to chemotherapy, highlighting current challenges and future perspectives. (3) Results: there is ample nonclinical evidence indicating that fasting can mitigate the toxicity of chemotherapy and/or increase the efficacy of chemotherapy. The relevant clinical research is encouraging, albeit still in its infancy. The path forward for implementing fasting in oncology is a personalized approach, entailing counteraction of current challenges, including: (i) patient selection; (ii) fasting patterns; (iii) timeline of fasting and refeeding; (iv) validation of biomarkers for assessment of fasting; and (v) establishment of protocols for patients' monitoring. (4) Conclusion: prescribing fasting as anticancer medicine may not be far away if large randomized clinical trials consolidate its safety and efficacy.
Enhancing endocrine therapy activity via fasting cycles: biological rationale and clinical feasibility. [2021]We found that periodic fasting increases the anti-cancer activity of endocrine agents used to treat hormone receptor-positive breast cancer and delays acquired resistance to them by reducing blood leptin, insulin and insulin-like growth factor 1 (IGF1). Our work supports further clinical studies of fasting as an adjuvant to endocrine agents in breast cancer patients.
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]In preclinical studies, fasting was found to potentiate the effects of several anticancer treatments, and early clinical studies indicated that patients may benefit from regimes of modified fasting. However, concerns remain over possible negative impact on the patients' nutritional status. We assessed the feasibility and safety of a 5-day "Fasting-Mimicking Diet" (FMD) as well as its effects on body composition and circulating growth factors, adipokines and cyto/chemokines in cancer patients. In this single-arm, phase I/II clinical trial, patients with solid or hematologic malignancy, low nutritional risk and undergoing active medical treatment received periodic FMD cycles. The body weight, handgrip strength and body composition were monitored throughout the study. Growth factors, adipokines and cyto/chemokines were assessed by ELISA. Ninety patients were enrolled, and FMD was administered every three weeks/once a month with an average of 6.3 FMD cycles/patient. FMD was largely safe with only mild side effects. The patients' weight and handgrip remained stable, the phase angle and fat-free mass increased, while the fat mass decreased. FMD reduced the serum c-peptide, IGF1, IGFBP3 and leptin levels, while increasing IGFBP1, and these modifications persisted for weeks beyond the FMD period. Thus, periodic FMD cycles are feasible and can be safely combined with standard antineoplastic treatments in cancer patients at low nutritional risk. The FMD resulted in reduced fat mass, insulin production and circulating IGF1 and leptin. This trial was registered on Clinicaltrials.gov in July 2018 with the identifier NCT03595540.
Decrease in early mortality for newly diagnosed multiple myeloma patients in the Netherlands: a population-based study. [2022]Identification of risk factors for early mortality (EM) in multiple myeloma (MM) patients may contribute to different therapeutic approaches in patients at risk for EM. This population-based study aimed to assess trends in EM and risk factors for EM among MM patients diagnosed in the Netherlands. All MM patients, newly diagnosed between 1989 and 2018, were identified in the Netherlands Cancer Registry. Patients were categorized into three calendar periods (1989-1998, 1999-2008, 2009-2018) and into five age groups (≤65, 66-70, 71-75, 76-80, >80 years). EM was defined as death by any cause ≤180 days post-diagnosis. We included 28,328 MM patients (median age 70 years; 55% males). EM decreased from 22% for patients diagnosed in 1989-1998 to 13% for patients diagnosed in 2009-2018 (P 70 years. Therefore, novel strategies should be explored to improve the outcome of patients at risk for EM.
Calorie restriction in cancer patients undergoing chemotherapy: Facts, phantasy or misunderstanding. [2022]Experimental studies in cancer cell lines and tumour-bearing animals support the concept that a short-period fasting could potentiate the effect of antineoplastic chemotherapy due to a particular metabolic adaptation normal cells whereas cancer cells would remain particularly sensitive to the toxic effects of the therapy. The potential of such approach is actually emphasized by the media but data in humans are very scant and many oncologists fear that peri-chemotherapy fasting might worsen the patient nutritional status. The aim of this review is to focus on the benefits versus the adverse effects of the peri-chemotherapy fasting and to clarify if discrepancy of opinions regarding this approach relies on data from clinical trials or simply on misunderstandings or prejudices.
Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells. [2023]More than ten randomized clinical trials are being tested to evaluate the efficacy, effectiveness and safety of a fasting-mimicking diet (FMD) combined with different antitumor agents.