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Breast CancerDIgesTNCT03454282

Impact of Dietary Intervention on Tumor Immunity: the DigesT Trial

A study testing FMD in people with Breast Cancer and Melanoma, Malignant, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This trial aims to assess the immunological and metabolic changes induced by the Fasting Mimicking Diet (FMD) in the pre-operative and post-operative setting in breast cancer and melanoma patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer, Melanoma, Malignant
What is being tested?
FMD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteItaly
Study dates
1 Jul 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 and ≤ 75 years.
  • Evidence of a personally signed and dated informed consent document (ICD) indicating that the patient has been informed of all pertinent aspects of the study before enrollment and FMD prescription.
  • Willingness and ability to comply with the FMD protocol, the scheduled visits, treatment plans, laboratory tests and other procedures.
  • Histologically confirmed diagnosis of invasive breast cancer candidate to curative surgery (Cohort A), or resected malignant melanoma requiring dissection of the regional lymph node basin for sentinel lymph node involvement (Cohort B), or malignant melanoma treated with curative surgery (including, in case, lymph node removal and lymph node dissection) (Cohort C). For breast cancer patients, any biological subgroup (including estrogen receptor-positive, HER2-positive, triple-negative breast cancer) will be admitted; HER2-positive tumors will be defined on the basis of an IHC score of 3, or a score of 2 with ISH evaluation indicative of gene amplification.
  • Availability of archival FFPE tissue blocks of primary breast cancer (Cohort A) or melanoma (Cohort B, Cohort C).
  • Presence of an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Show all 25Show fewer
  • Presence of adequate bone marrow and organ function as defined by the following laboratory values:
  • ANC ≥ 1.5 x 109/l
  • platelets ≥ 100 x 109/l
  • hemoglobin ≥ 9.0 g/dl
  • calcium (corrected for serum albumin) within normal limits or ≤ grade 1 according to NCI-CTCAE version 4.03 if not clinically significant
  • potassium within the normal limits, or corrected with supplements
  • creatinine < 1.5 ULN
  • blood uric acid < 10 mg/dl
  • ALT and AST ≤ 2.5 x ULN
  • total bilirubin < ULN except for patients with Gilbert syndrome who may only be included in the total bilirubin is < 3.0 x ULN or direct bilirubin < 1.5 x ULN
  • Albumin > 3 g/dL
  • Fasting glucose ≤ 200 mg/dl.
  • Total Cholesterol ≤ 300 mg/dl.
  • Triglycerides ≤ 300 mg/dl.
  • Female patients of childbearing potential must agree to sexual abstinence or to use two highly effective method of contraception throughout the study and for at least 30 days after the end of the FMD. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year. Barrier methods must always be supplemented with the use of a spermicide. A patient is of childbearing potential if, in the opinion of the Investigator, she is biologically capable of having children and is sexually active.
  • Female patients are not of childbearing potential if they meet at least one of the following criteria:
  • Have undergone a documented hysterectomy and/or bilateral oophorectomy
  • Have medically confirmed ovarian failure
  • Achieved post-menopausal status, defined as: (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries) and have a serum FSH level within the laboratory's reference range for postmenopausal females.

Who cannot join

  • Prior systemic treatment for breast cancer or melanoma.
  • Diagnosis of a concurrent malignancy other than breast cancer or melanoma, or malignancy other than breast cancer or melanoma diagnosed within 5 years of treatment enrollment, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
  • Body Mass Index (BMI) < 20 Kg/m2.
  • Anamnesis of alcohol abuse.
  • Unintentional weight loss ≥ 5% in the last three months, unless the patient has a BMI > 25 Kg/m2 at study enrollment. Intentional weight loss is permitted if < 10% in the last three months and patient BMI is > 22 kg/m2.
  • Severe heart, liver, pulmonary, kidney comorbidities.
Show all 25Show fewer
  • Current status of pregnancy or lactation, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
  • Active HBV or HCV infection.
  • Severe infections within 4 weeks prior to FMD initiation, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Active autoimmune diseases that require systemic treatment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • History of recent diagnosis of hypothyroidism for which replacement therapy (eg., thyroxine) and blood endocrine profile are not stabilized yet.
  • Established diagnosis of diabetes mellitus type I or diabetes mellitus type II that requires pharmacological treatment (including, but not limited to, insulin, insulin secretagogues and metformin).
  • Severe impairment of the gastrointestinal (GI) function or GI disease that may alter the digestion and absorption of nutrients during the re-feeding phase (e.g. active ulcerative diseases of the stomach or intestine, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Known history of Human Immunodeficiency Virus (HIV) infection.
  • Clinically significant heart disease and/or recent cardiac events including:
  • history of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 12 months prior to the start of study treatment;
  • history of documented congestive heart failure (NYHA III-IV);
  • documented cardiomyopathy.
  • History of cardiac arythmias, (e.g. ventricular tachycardia, chronic atrial fibrillation), complete left bundle branch block, high grade AV block (e.g. bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.
  • Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100 mmHg, with or without anti-hypertensive medication.
  • Known reduction of left-ventricular ejection fraction (LVEF) to less than 50%, as assessed by multigated radionuclide scintigraphic scan (MUGA) or echocardiography.
  • Previous episodes of symptomatic hypotension causing unconsciousness.
  • Baseline fasting plasma glucose ≤ 65 mg/dl.
  • Ongoing therapy with systemic corticosteroids, or systemic corticosteroid therapy ≤ 2 weeks before study enrollment, or who have not recovered from side effects of such treatment. The following uses of corticosteroids are permitted: topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airways diseases), eye drops.
  • Any serious medical or psychiatric illness that in the assessment of the investigator renders the patient not suitable for participation in this clinical study.

Trial locations and contacts

1 site in 1 country.

Filippo De Braud, Professor contact

0039 02/23902148

filippo.debraud@istitutotumori.mi.it

Claudio Vernieri, MD contact

0039 02/23903066

claudio.vernieri@istitutotumori.mi.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Claudio Vernieri, M.D., Ph.D., +39 02 23903066, claudio.vernieri@istitutotumori.mi.it

    Recruiting

Other trials in Italy

About this study

Official title: Impact of Dietary Intervention on Tumor Immunity: the DigesT Trial.

This trial aims to assess the immunological and metabolic changes induced by the Fasting Mimicking Diet (FMD) in the pre-operative and post-operative setting in breast cancer and melanoma patients. Three cohorts of patients will be enrolled: 1) Cohort A: patients with resectable breast cancer (cT1N0M0 stage or cT1cN1M0-cT2cN0M0 stages not requiring pre-operative systemic treatment at the judgment of the investigator) who are candidate to curative surgery; 2) Cohort B: patients with malignant melanoma patients candidate to dissection of the lymph node basin because of a positive sentinel lymph node (stage IIIA-IIIB-IIIC); 3) Cohort C: patients with resected malignant melanoma (including radicalization and, in case, lymph node dissection) who are not candidate to any adjuvant treatment, but only to clinical and radiological follow-up (stage IIB-IIC). Patients in cohorts A and B will undergo one 5-days FMD cycle about 13-15 days before surgical removal of primary tumor (breast) or lymph nodes (breast, melanoma). Patients in cohort C will undergo 4 consecutive FMD cycles every 28 days, starting one month after surgery.

Read the detailed description

Preclinical evidences suggest that reducing the concentration of blood metabolites and growth factors reduces the in vivo growth of several tumor models, while protecting normal tissues from the cytotoxic effects of chemotherapeutical treatments. In recent years, a plant-based, calorie-restricted, low-carbohydrate, low-protein diet, also known as Fasting Mimicking Diet (FMD), has been proposed as a potential anticancer dietary intervention. The FMD is safe when administered cyclically (every 21-28 days) to healthy volunteers, and is capable of significantly reducing the concentration of plasma glucose, serum insulin and IGF-1, while increasing levels of plasma IGFBPs and ketone bodies. The FMD has been shown to inhibit the in vivo growth of several tumor models, including breast cancer and melanoma mice models. The anticancer effects of the FMD are likely mediated by two concomitant mechanisms: 1) one direct anticancer effect that is mediated by the inhibition of energy production and anabolic pathways, such as protein and fatty acid synthesis, in cancer cells; 2) one indirect effect that is mediated by the activation of antitumor immunity, with the result of enhanced tumor infiltration by cytotoxic CD8+ T-lymphocytes and reduced infiltration by immunosuppressive populations. According to the currently accepted model, the anticancer and immunomodulatory effects of the FMD mostly derive from the reduction of circulating glucose, insulin and IGF-1 levels, and a parallel increase of ketone body and IGF-1 binding protein concentration. However, recent observations in healthy volunteers and cancer patients, suggest that FMD-mediated changes in many other metabolites, such as specific amino acids or fatty acids, could contribute to the cell-autonomous or immune-mediated anticancer effects of the FMD. While the study of the effects of the FMD in combination with standard treatments (e.g. chemotherapy, molecular targeted therapy) in advanced cancers represents the final objective of the ongoing studies, fully uncovering the metabolic and immunological effects of the FMD alone is essential to design future combination studies. From this perspective, the pre- and post-operative clinical settings in cancer patients who are not candidate to other medical treatments represent an ideal context to assess the effects of the FMD without other confounding factors. This trial primarily aims to assess the immunological and metabolic changes induced by the FMD in the pre-operative and post-operative setting in breast cancer and melanoma patients. Three cohorts of patients will be enrolled: 1) Cohort A: patients with resectable breast cancer (cT1N0M0 stage or cT1cN1M0-cT2cN0M0 stages not requiring pre-operative systemic treatment at the judgment of the investigator) who are candidate to curative surgery; 2) Cohort B: patients with malignant melanoma patients candidate to dissection of the lymph node basin because of a positive sentinel lymph node (stage IIIA-IIIB-IIIC); 3) Cohort C: patients with resected malignant melanoma (including radicalization and, in case, lymph node dissection) who are not candidate to any adjuvant treatment, but only to clinical and radiological follow-up (stage IIB-IIC). Patients in cohorts A and B will undergo one 5-days FMD cycle about 13-15 days before surgical removal of primary tumor (breast) or lymph nodes (breast, melanoma). Patients in cohort C will undergo 4 consecutive FMD cycles every 28 days, starting one month after surgery.

Being tested
FMD
Keywords
Breast, Cancer, Malignant, Melanoma, Fasting Mimicking Diet (FMD), Tumor, Immunity, Metabolic Effects, Immunological Effects
Medical subject headings
Breast Neoplasms, Melanoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FMDOther

    Also called Fasting Mimicking Diet

    The Fasting Mimicking Diet (or FMD) consists in a 5-day plant-based, low-calorie (about 600 Kcal on day 1, followed by about 300 KCal/day on days 2 to 5), low-carbohydrate low-protein diet

Study groups in NCT03454282
Study groupRoleWhat they receive
FMD ArmExperimentalThe intervention consists in 5-day FMD (Fasting Mimicking Diet) to be followed for one cycle (Cohorts A and B) or for 4 consecutive every-four week cycles postoperatively.
Receives: Other: FMD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute and relative changes in PBMCs

    Absolute and relative changes in PBMCs by 10-color cytofluorimetry before and after the FMD.

    Measured: 3 years

Secondary outcomes (33)

  1. Phenotypic modifications in PBMCs

    Phenotypic modifications in PBMCs, as detected by by 10-colors citofluorimetry and single-cell "mass cytometry" (CyTOF)

    Measured: 3 years

  2. Functional modifications in PBMCs

    Functional modifications in PBMCs, as detected by by 10-colors citofluorimetry and single-cell "mass cytometry" (CyTOF)

    Measured: 3 years

  3. Functional modifications in tumor-infiltrating lymphocytes

    Functional modifications in tumor-infiltrating lymphocytes, as detected by by 10-colors citofluorimetry and single-cell "mass cytometry" (CyTOF)

    Measured: 3 years

  4. Phenotypic modifications in tumor-infiltrating lymphocytes

    Phenotypic modifications in tumor-infiltrating lymphocytes, as detected by by 10-colors citofluorimetry and single-cell "mass cytometry" (CyTOF)

    Measured: 3 years

  5. Functional modifications of immune cell population in LNs

    Functional modifications of immune cell populations in LNs, as detected by single-cell "mass cytometry" (CyTOF).

    Measured: 3 years

  6. mRNA profiling in tumor cells

    Gene expression profiling (through mRNA quantification) in tumor cells (Cohort A).

    Measured: 3 years

  7. mRNA profiling in immune cells

    Gene expression profiling (through mRNA quantification) in PBMCs and immune cell populations inside lymph nodes (Cohort B).

    Measured: 3 years

  8. miRNA profiling in tumor cells

    miRNA profiling in tumor cells (Cohort A)

    Measured: 3 years

  9. miRNA profiling in immune cells

    miRNA profiling in PBMCs and immune cell populations inside lymph nodes (Cohort B).

    Measured: 3 years

  10. Changes in the expression of metabolic genes in PBMCs

    Changes in the expression of selected metabolic genes (including hexokinase 1, phosphofructokinase 1, pyruvate kinase 2) through mRNA quantification in PBMCs before and after the FMD.

    Measured: 3 years

  11. FMD-induced changes in blood metabolic parameters

    FMD-induced changes in blood (glucose, triglycerides, fatty acids, cholesterol, amino acids)

    Measured: 3 years

  12. FMD-induced changes in urine metabolites

    FMD-induced changes in urine metabolites (ketone bodies)

    Measured: 3 years

  13. FMD-induced changes in serum growth factors.

    FMD-induced changes in serum growth factors.

    Measured: 3 years

  14. Qualitative changes in tumor-infiltrating immune cells

    Qualitative changes in the type of tumor-infiltrating immune cell populations before and after the diet in breast cancer patients undergoing curative surgery (Cohort A).

    Measured: 3 years

  15. Quantitative changes in tumor-infiltrating immune cells

    Quantitative changes in the number of tumor-infiltrating lymphocytes, machrophages, MDSCs before and after the diet in breast cancer patients undergoing curative surgery (Cohort A).

    Measured: 3 years

  16. Changes in tumor proliferation

    Changes in tumor proliferation index (Ki67) IHC in breast cancer patients (Cohort A).

    Measured: 3 years

  17. Changes in tumor cell apoptosis

    Changes in tumor cell apoptosis (caspase 3 by IHC) in breast cancer patients (Cohort A).

    Measured: 3 years

  18. Changes in tumor metabolic pathways

    Changes in tumor levels of glycolytic enzymes by IHC (Glut1, HK1, PFK1/2, PK2) in breast cancer patients (Cohort A).

    Measured: 3 years

  19. Changes in expression of hormone receptors and HER2

    Changes in expression of estrogen and/progesterone receptor and HER2 oncoprotein by IHC in breast cancer patients (Cohort A).

    Measured: 3 years

  20. Qualitative changes in immune cell suspensions from lymph nodes

    Changes in the type of immune cells (CD8+ T-lymhocytes, CD 4+ lymphocytes, Treg) found in lymph node suspensions of melanoma patients undergoing one FMD cycle before lymph node dissection (Cohort B).

    Measured: 3 years

  21. Quantitative changes in immune cell suspensions from lymph nodes

    Quantitative changes in the absolute and relative amount of immune cell populations in lymph node suspensions of melanoma patients undergoing one FMD cycle before lymph node dissection (Cohort B).

    Measured: 3 years

  22. Changes in DNA methylomic profiles in lymph node specimens

    Changes in genome-wide DNA methylomic profiles with high-density arrays in lymph node specimens from patients undergoing the FMD before surgery (Cohorts A and B).

    Measured: 3 years

  23. Changes in DNA methylomic profiles in tumor specimens

    Changes in genome-wide DNA methylomic profiles with high-density arrays in tumor specimens from patients undergoing the FMD before surgery (Cohorts A and B).

    Measured: 3 years

  24. Changes in gut microbiota composition.

    Changes in type of gut bacteria populations, as detected through 16S ribosomal RNA sequencing

    Measured: 3 years

  25. Short-term modification of blood nutritional parameters.

    Short-term (before vs after each FMD cycle) modification of blood nutritional parameters (levels of plasma cholesterol, prealbumin, transferrin, total lymphocytes)

    Measured: 3 years

  26. Long-term modification of blood nutritional parameters.

    Long-term (along subsequent FMD cycles) modification of blood nutritional parameters (levels of plasma cholesterol, realbumin, transferrin, total lymphocytes)

    Measured: 3 years

  27. Short-term and long-term modification of BMI

    Short-term and long-term modification of BMI

    Measured: 3 years

  28. FMD-induced changes in white blood cell populations

    FMD-induced changes in neutrophils, macrophages, lymphocytes

    Measured: 3 years

  29. FMD-induced changes in hemoglobin

    FMD-induced changes in hemoglobin

    Measured: 3 years

  30. Assessment of patient compliance to the FMD.

    Assessment of patient compliance to the FMD, as measured by quantifying the number of major and minor deviations of patients' diet relative to the prescribed FMD scheme

    Measured: 3 years

  31. Assessment of FMD tolerability.

    Assessment of FMD tolerability, as defined by the occurrence of G3-G4 adverse events, or serious adverse events (SAEs)

    Measured: 3 years

  32. Correlation between FMD-induced changes in serum metabolites and changes in PBMCs

    Correlation between FMD-induced changes in serum metabolites and changes in PBMCs, their activation status, and characteristics of tumor cell and immune infiltrate.

    Measured: 3 years

  33. Correlation between FMD-induced metabolic and immunological changes

    Correlation between FMD-induced metabolic and immunological changes with patient diet evaluated at study enrollment through food diaries.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2018
  2. Study start1 Jul 2018
  3. Primary completion30 May 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Clinical trials with a single arm and three cohorts of patients
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03454282
Sponsor's protocol ID
INT157/17
Other IDs
B42F17000260006
Acronym
DIgesT
Status last verified
Feb 2019
First submitted
29 Jan 2018
Last updated
26 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013.

    PubMed 21376230

  • Vernieri C, Casola S, Foiani M, Pietrantonio F, de Braud F, Longo V. Targeting Cancer Metabolism: Dietary and Pharmacologic Interventions. Cancer Discov. 2016 Dec;6(12):1315-1333. doi: 10.1158/2159-8290.CD-16-0615. Epub 2016 Nov 21.

    PubMed 27872127

  • Vander Heiden MG, Cantley LC, Thompson CB. Understanding the Warburg effect: the metabolic requirements of cell proliferation. Science. 2009 May 22;324(5930):1029-33. doi: 10.1126/science.1160809.

    PubMed 19460998

  • Locasale JW, Grassian AR, Melman T, Lyssiotis CA, Mattaini KR, Bass AJ, Heffron G, Metallo CM, Muranen T, Sharfi H, Sasaki AT, Anastasiou D, Mullarky E, Vokes NI, Sasaki M, Beroukhim R, Stephanopoulos G, Ligon AH, Meyerson M, Richardson AL, Chin L, Wagner G, Asara JM, Brugge JS, Cantley LC, Vander Heiden MG. Phosphoglycerate dehydrogenase diverts glycolytic flux and contributes to oncogenesis. Nat Genet. 2011 Jul 31;43(9):869-74. doi: 10.1038/ng.890.

    PubMed 21804546

  • Mankoff DA, Eary JF, Link JM, Muzi M, Rajendran JG, Spence AM, Krohn KA. Tumor-specific positron emission tomography imaging in patients: [18F] fluorodeoxyglucose and beyond. Clin Cancer Res. 2007 Jun 15;13(12):3460-9. doi: 10.1158/1078-0432.CCR-07-0074.

    PubMed 17575208

  • Sullivan LB, Gui DY, Hosios AM, Bush LN, Freinkman E, Vander Heiden MG. Supporting Aspartate Biosynthesis Is an Essential Function of Respiration in Proliferating Cells. Cell. 2015 Jul 30;162(3):552-63. doi: 10.1016/j.cell.2015.07.017.

    PubMed 26232225

  • Menendez JA, Lupu R. Fatty acid synthase and the lipogenic phenotype in cancer pathogenesis. Nat Rev Cancer. 2007 Oct;7(10):763-77. doi: 10.1038/nrc2222.

    PubMed 17882277

  • Menendez JA, Vellon L, Mehmi I, Oza BP, Ropero S, Colomer R, Lupu R. Inhibition of fatty acid synthase (FAS) suppresses HER2/neu (erbB-2) oncogene overexpression in cancer cells. Proc Natl Acad Sci U S A. 2004 Jul 20;101(29):10715-20. doi: 10.1073/pnas.0403390101. Epub 2004 Jul 2.

    PubMed 15235125

  • Yang YA, Han WF, Morin PJ, Chrest FJ, Pizer ES. Activation of fatty acid synthesis during neoplastic transformation: role of mitogen-activated protein kinase and phosphatidylinositol 3-kinase. Exp Cell Res. 2002 Sep 10;279(1):80-90. doi: 10.1006/excr.2002.5600.

    PubMed 12213216

  • Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31.

    PubMed 26027431

  • Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbe C, Ferraresi V, Smylie M, Weber JS, Maio M, Bastholt L, Mortier L, Thomas L, Tahir S, Hauschild A, Hassel JC, Hodi FS, Taitt C, de Pril V, de Schaetzen G, Suciu S, Testori A. Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy. N Engl J Med. 2016 Nov 10;375(19):1845-1855. doi: 10.1056/NEJMoa1611299. Epub 2016 Oct 7.

    PubMed 27717298

  • Lee C, Raffaghello L, Brandhorst S, Safdie FM, Bianchi G, Martin-Montalvo A, Pistoia V, Wei M, Hwang S, Merlino A, Emionite L, de Cabo R, Longo VD. Fasting cycles retard growth of tumors and sensitize a range of cancer cell types to chemotherapy. Sci Transl Med. 2012 Mar 7;4(124):124ra27. doi: 10.1126/scitranslmed.3003293. Epub 2012 Feb 8.

    PubMed 22323820

  • Brandhorst S, Wei M, Hwang S, Morgan TE, Longo VD. Short-term calorie and protein restriction provide partial protection from chemotoxicity but do not delay glioma progression. Exp Gerontol. 2013 Oct;48(10):1120-8. doi: 10.1016/j.exger.2013.02.016. Epub 2013 Feb 21.

    PubMed 23454633

  • Lee C, Safdie FM, Raffaghello L, Wei M, Madia F, Parrella E, Hwang D, Cohen P, Bianchi G, Longo VD. Reduced levels of IGF-I mediate differential protection of normal and cancer cells in response to fasting and improve chemotherapeutic index. Cancer Res. 2010 Feb 15;70(4):1564-72. doi: 10.1158/0008-5472.CAN-09-3228. Epub 2010 Feb 9.

    PubMed 20145127

  • Safdie FM, Dorff T, Quinn D, Fontana L, Wei M, Lee C, Cohen P, Longo VD. Fasting and cancer treatment in humans: A case series report. Aging (Albany NY). 2009 Dec 31;1(12):988-1007. doi: 10.18632/aging.100114.

    PubMed 20157582

Questions about this trial

What is this clinical trial studying?

A study testing FMD in people with Breast Cancer and Melanoma, Malignant, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Filippo De Braud, Professor (0039 02/23902148, filippo.debraud@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute and relative changes in PBMCs (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03454282, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.

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