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Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03595540
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alessio Nencioni, University of Genova

Brief Summary:
This is a pilot, single arm prospective trial assessing feasibility, safety and effects on patient nutritional status of a 5-day fasting-mimicking diet (FMD) in patients with different cancer types and concomitant anticancer treatment.

Condition or disease Intervention/treatment Phase
Cancer Breast Cancer Colorectal Cancer Other: Prolon Not Applicable

Detailed Description:

It is proposed to conduct a single-arm phase II clinical study of a FMD (Prolon, by L-Nutra) in 60 patients with solid or hematologic tumors who undergo treatment with chemotherapeutic regimens, hormone therapies, other molecularly targeted therapies (including kinase inhibitors), biological drugs (including trastuzumab, pertuzumab, cetuximab and bevacizumab) or inhibitors of immune checkpoints (e.g. Opdivo, Keytruda).

Prolon is a FMD lasting five days. It consist of vegetable soups, broths, bars, olives, crackers, herbal teas, supplements of vitamins and minerals. Day 1 of the FMD supplies ~4600 kJ (11% protein, 46% fat, and 43% carbohydrate), whereas days 2-to-5 provide ~3000 kJ (9% protein, 44% fat, and 47% carbohydrate) per day.

Primary endpoints of the study are the feasibility and safety of monthly cycles of the FMD in patients with solid or hematologic tumors who undergo active treatment. Feasibility is monitored through the compilation of a food diary and is defined as the strict adherence to the diet prescribed in all its days with the possibility of admitting the consumption of only 50% of the planned diet and / or a maximum consumption of 4-5 Kcal / kg body weight of food not provided in only one of the five days of each cycle. Furthermore, the dosage of IGF-1 and of urinary ketone bodies allow to identify further cases of non-adherence to the diet.

FMD-emergent side effects are monitored according to the NCI-CTCAE version 5.0.

Secondary endpoints include:

  • patient nutritional status as monitored by weight, handgrip strength, bio-impedance and serum markers (ferritin, transferrin, colinesterase).
  • Quality of life (QLQ-C30)
  • Clinical responses measured by CT, MRI or by blood chemistry tests, dosing of tumor markers and / or molecular biology tests in the case of prostate tumors or hematologic tumors (e.g. PSA in patients affected by prostate cancer, BCR / Abl mRNA in the case of patients undergoing treatment with kinase inhibitors for CML; CM in the case of patients undergoing treatment for multiple myeloma).
  • Long-term efficacy (progression-free survival, overall survival).
  • Effect of FMD on HOMA index, PCR, circulating levels of IGF-1 and urinary levels of ketone bodies.
  • Effect of FMD on lymphocyte subsets, NK cells and antigen-presenting cells with a role documented in antitumor immunity.

It is foreseen that 60 patients will be enrolled.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot, single arm prospective trial assessing feasibility and safety of a 5-day fasting-mimicking diet in patients with different cancer types and concomitant anticancer treatments.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase II Clinical Study of a Fasting-mimicking Diet in Patients Undergoing Oncologic Treatment
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : September 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prolon - FMD
Patients undergoing active cancer treatment are assigned monthly cycles of the fasting-mimicking diet Prolon
Other: Prolon
Prolon by L-Nutra is a medically-designed dietary kit providing the food to eat for five days. Day 1 of Prolon provides ~4600 kJ (11% protein, 46% fat, and 43% carbohydrate), whereas days 2-to-5 provide ~3000 kJ (9% protein, 44% fat, and 47% carbohydrate) per day.
Other Name: fasting-mimicking diet




Primary Outcome Measures :
  1. percentage of prescribed diet consumed and intake of any extra food [ Time Frame: 6 months ]
    Feasibility will be monitored through the compilation of a food diary and is defined as the strict adherence to the diet prescribed in all its days with the possibility to admit the consumption of only 50% of the planned diet and / or a maximum consumption of 4- 5 Kcal / kg of food not expected in only one of the days -2, -1, +1 of each cycle.

  2. Quantification of FMD-emergent adverse events [ Time Frame: 6 months ]
    The side effects of Prolon (hematologic and non-hematologic) will be classified according to NCI CTCAE 5.0



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:

  • Written informed consent
  • Age > 18 years
  • Patients with solid or hematologic tumors undergoing active treatment, including patients who are preparing to start a new treatment with chemotherapeutic regimens, hormone therapies, other molecularly targeted therapies (including kinase inhibitors), biologics (including trastuzumab) , pertuzumab, cetuximab and bevacizumab) or inhibitors of immune checkpoints (eg Opdivo, Keytruda), ie patients in whom treatment is already underway;
  • ECOG performance status 0-1
  • Adequate organ function
  • BMI >21 kg/m2 (with possibility to also enroll patients with 19<BMI<21 based on the judgement of the treating physician)
  • Low nutritional risk according to nutritional risk screening (NRS)

Exclusion criteria:

  • Diabetes mellitus;
  • Previous therapy with IGF-1 inhibitors;
  • Food allergies to the components of the FMD;
  • BMI <19 kg/m2;
  • bio-impedance phase angle <5.0°;
  • medium/high nutritional risk according to NRS;
  • Any metabolic disorder that can affect gluconeogenesis or ability to adapt to fasting periods;
  • Patients who live alone or are not adequately supported by the family context;
  • Treatment in progress with other experimental therapies.

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): NCT03595540


Contacts
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Contact: Alessio Nencioni, MD +39 010 353 ext 1 alessio.nencioni@unige.it

Locations
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Italy
Alessio Nencioni Recruiting
Genoa, GE, Italy, 16132
Contact: Alessio Nencioni, MD    +39 010 353 ext 8990    alessio.nencioni@unige.it   
Sponsors and Collaborators
University of Genova
Investigators
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Principal Investigator: Alessio Nencioni, MD University of Genoa

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Responsible Party: Alessio Nencioni, Associate Professor, University of Genova
ClinicalTrials.gov Identifier: NCT03595540    
Other Study ID Numbers: 308CER2017
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
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 Alessio Nencioni, University of Genova:
fasting-mimicking diet
cancer
nutritional status
body composition
fasting
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases