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Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients

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ClinicalTrials.gov Identifier: NCT03340935
Recruitment Status : Active, not recruiting
First Posted : November 14, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
University of Milan
Information provided by (Responsible Party):
Filippo de Braud, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
In preclinical studies, cyclic calorie-restricted diets reduce the risk of several cancers and improve the antitumor activity of standard treatments against already established malignancies.In particular, the fasting mimicking diet (FMD), a plant-based, calorie-restricted, low carbohydrate, low-protein diet to be repeated cyclically every 3-4 weeks, enhances the antitumor activity of cytotoxic chemotherapy, while contemporarily protecting healthy tissues and stimulating antitumor immunity. Most of these effects are likely mediated by the reduction of blood glycemia and growth factors, such as insulin and insulin-like growth factor 1 (IGF-1). When administered to healthy volunteers, cyclic FMD has been shown to be safe and capable of reducing risk factors for different chronic diseases. However, the effects of the FMD in cancer patient populations have not been evaluated so far. This study aims to assess the safety, feasibility and metabolic effects of the FMD in cancer patients treated with different standard antitumor therapies. Patients with any malignancy, with the exception of small cell neuroendocrine tumors, will be considered for enrollment in this study. The FMD will be administered up to a maximum of 8 consecutive cycles in combination with standard adjuvant treatments or therapies for advanced disease.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Cancer Other: Fasting mimicking diet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : March 30, 2019
Estimated Study Completion Date : April 30, 2019

Arm Intervention/treatment
Experimental: Fasting mimicking diet
Fasting mimicking diet (FMD)
Other: Fasting mimicking diet
Fasting Mimicking Diet (or FMD) consists in a 5-day plant-based, low-calorie (600 Kcal on day 1, followed by 300 KCal/day on days 2 to 5), low-protein, low carbohydrate diet




Primary Outcome Measures :
  1. Safety of the fasting mimicking diet (FMD) in cancer patients [ Time Frame: 2 years ]
    Safety is assessed by recording each adverse (AE) occurring during the period on diet. All AEs will be graded according to the NCI CTCAE v 4.03. Serious adverse events (SAEs) will be also reported.


Secondary Outcome Measures :
  1. Feasibility of the FMD in cancer patients [ Time Frame: 16 months ]
    Feasibility is defined as the ability of the patient to comply with the prescribed dietary regimen. It will be assessed through the analysis of food diaries filled by patients during the five days of each FMD cycle.

  2. Metabolic effects of the FMD [ Time Frame: 16 months ]
    FMD-induced metabolic changes will be evaluated by measuring blood metabolites (glucose, cholesterol, triglycerides) and urinary ketone bodies before and at the completion of each FMD cycle.

  3. Effects of the FMD on blood growth factors [ Time Frame: 16 months ]
    FMD-induced changes in blood growth factors will be evaluated by measuring modifications of plasma insulin and serun insulin-like growth factor 1 (IGF-1) concentration before and at the completion of each FMD cycle

  4. Weight changes during the FMD [ Time Frame: 16 months ]
    Percent changes in body weight will be measured during each FMD cycle and across subsequent FMD cycles.

  5. Changes in blood cell counts [ Time Frame: 16 months ]
    FMD-induced changes in blood cell counts

  6. Changes in kidney function parameters. [ Time Frame: 16 months ]
    FMD-induced changes in parameters linked to kidney function, such as blood urea nitrogen, creatinine and uric acid.

  7. Changes in liver parameters [ Time Frame: 16 months ]
    FMD-induced changes in parameters linked to liver function, such as aspartate and alanine transaminases, total bilirubin.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Cytologically or Histologically confirmed diagnosis of malignant neoplasm
  • Capability of swallowing plant-based foods foreseen by the FMD
  • Body mass index (BMI) ≥ 20 kg/m2
  • Adequate bone marrow function, including:

    1. Hemoglobin > 9 g/dl
    2. Piatelets > 75,000/µl
    3. Absolute neutrophil count (ANC) > 1,500/µl
  • Creatinine < 1.5 mg/dl or calculated creatinine clearance ≥50 mL/min
  • Uric acid < 6 mg/dl
  • Fasting glucose > 65 mg/dl
  • Total bilirubin < 2 mg/dl or < ULN, except for patients with Gilbert syndrome
  • Written informed consent according to the local Ethics Committee requirements
  • Willing and ability to accomplish blood and urinary examinations according to the protocol
  • Ability to maintain a daily contact (by phone or email) with the study staff for the communication of crucial clinical information, including daily body weight, blood pressure, health status and adverse events during each of the 5 days on diet

Exclusion criteria:

  • Small cell neuroendocrine carcinoma
  • Unintentional weight loss ≥ 5% in the last 3-6 months
  • Known HIV infection
  • Pregnancy or lactation
  • History of alcohol abuse
  • Diagnosis of diabetes mellitus type I or type II that requires medical treatment
  • Fasting glucose > 200 mg/dl
  • Clinically meaningful cardiovascular, renal or pulmonary diseases
  • Current treatment with antipsychotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340935


Locations
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Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Sponsors and Collaborators
Filippo de Braud
University of Milan
Investigators
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Principal Investigator: Filippo de Braud, M.D. SC Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale dei Tumori

Publications of Results:

Other Publications:
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Responsible Party: Filippo de Braud, Dean of Medical Oncology and Hematology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03340935     History of Changes
Other Study ID Numbers: INT 10/17
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Filippo de Braud, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
fasting mimicking diet
malignant neoplasm
metabolism
metabolic effects
adjuvant treatment
metastatic setting

Additional relevant MeSH terms:
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Neoplasms