Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment

NCT03595540 | Completed

• 1 other identifier: 308CER2017
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Breast Cancer; Colorectal Cancer

Keywords

fasting-mimicking diet; cancer; nutritional status; body composition; fasting

Outcome Measures

Primary Outcomes (2)

• percentage of prescribed diet consumed and intake of any extra food

  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.

  6 months

• Quantification of FMD-emergent adverse events

  The side effects of Prolon (hematologic and non-hematologic) will be classified according to NCI CTCAE 5.0

  6 months

Study Arms (1)

Prolon - FMD

EXPERIMENTAL

Patients undergoing active cancer treatment are assigned monthly cycles of the fasting-mimicking diet Prolon

Other: Prolon

Interventions

Prolon OTHER

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.

Also known as: fasting-mimicking diet

Prolon - FMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Genova: lead

Study Sites (1)

Alessio Nencioni

Genoa, GE, 16132, Italy

Location

Related Publications (1)

• Valdemarin F, Caffa I, Persia A, Cremonini AL, Ferrando L, Tagliafico L, Tagliafico A, Guijarro A, Carbone F, Ministrini S, Bertolotto M, Becherini P, Bonfiglio T, Giannotti C, Khalifa A, Ghanem M, Cea M, Sucameli M, Murialdo R, Barbero V, Gradaschi R, Bruzzone F, Borgarelli C, Lambertini M, Vernieri C, Zoppoli G, Longo VD, Montecucco F, Sukkar SG, Nencioni A. Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment. Cancers (Basel). 2021 Aug 9;13(16):4013. doi: 10.3390/cancers13164013.

  PMID: 34439167 DERIVED

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Fasting

Interventions

Gestyl

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Feeding Behavior; Behavior

Study Officials

• Alessio Nencioni, MD

  Universita degli Studi di Genova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 23, 2018
• Study Start: November 22, 2017
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)