Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment

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

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Alessio Nencioni, MD; University of Genoa

More Information

• Responsible Party: Alessio Nencioni, Associate Professor, University of Genova
• ClinicalTrials.gov Identifier: NCT03595540
• Other Study ID Numbers: 308CER2017
• First Posted: July 23, 2018
• Last Update Posted: August 2, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases