Metabolic and Immunological Effects of a Modified Fasting Regimen in Cancer Patients

NCT05748704 | Unknown

• 1 other identifier: STMF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm prospective pilot study assessing the metabolic and immunologic effects of a modified fasting regimen in cancer patients with different cancer types and concomitant anticancer treatment.

Conditions

Cancer

Keywords

fasting; short-term modified fasting

Outcome Measures

Primary Outcomes (6)

• Effects of the STMF on IGF1 and IGFBP1

  IGF1 and IGFBP1 dosage (μg/l)

  month 1-12

• Effects of the STMF on IGFBP3

  IGFBP1 dosage (mg/l)

  month 1-12

• Effects of the STMF on Interleukin-6 (IL-6), interleukin-1 beta (IL1-beta) and tumor necrosis factor-alpha (TNF-alpha)

  IL-6, IL-1beta and TNF-alpha dosage (pg/ml)

  month 1-12

• Effects of the STMF on insulin

  Insulin dosage (mLU/L)

  month 1-12

• Effects of the STMF on adiponectin

  Adiponectin dosage (μg/ml)

  month 1-12

• Effects of the STMF on leptin

  Leptin dosage (ng/ml)

  month 1-12

Secondary Outcomes (8)

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

  3 to 8 weeks depending on the patient's therapy

• Quantification of emergent adverse events

  3 to 8 weeks depending on the patient's therapy

• Body Weight

  3 to 8 weeks depending on the patient's therapy

• Effect of STMF on circulating tumor DNA

  month 1-12

• Effect of the STMF on the intestinal microbiome

  month 1-3

Study Arms (1)

Short-term modified fasting

EXPERIMENTAL

The STMF regimen consists of a low-calorie diet lasting five days and aimed at providing between 800 and 1,000 kcal/day (tentatively 10% carbohydrates, 15% proteins, 75% lipids).

Other: Short-term modified fasting

Interventions

Short-term modified fasting OTHER

STMF regimen consists of a low-calorie diet aimed at providing 800-1,000 kcal/day, lasting five days and with the following composition: 10% carbohydrates, 15% proteins, 75% lipids. During the days of STMF, patients will be required to write down the foods consumed in a food diary in order to calculate calorie and nutrients intake. The STMF regimen will be administered tentatively on a monthly basis (depending on the therapeutic regimen the patient undergoes) and in any case no more frequently than once every three weeks.

Short-term modified fasting

Eligibility Criteria

• Age: 18 Years - 65 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 chemotherapy regimens, hormone therapies, other molecularly targeted therapies - including kinase inhibitors, biologicals or inhibitors of immune checkpoints; patients in whom treatment is already ongoing are also eligible; patients with haematological malignancies who are managed by watchful waiting (e.g. low-risk B-CLL or follicular lymphoma) as well as patients with relapsing forms of non-melanoma skin cancer (basal or squamous cell carcinoma) are also eligible.
• ECOG performance status 0-1
• Adequate organ function
• BMI \>21 kg/m2 (with possibility to also enroll patients with 18.5\<BMI\<21 based on the judgement of the treating physician)
• Low nutritional risk according to nutritional risk screening (NRS)

You may not qualify if:

• Age\> 65 years \[with the possibility to enroll from 65 to 75 years old patients if considered safe by the examining doctor
• Diabetes mellitus;
• BMI \<18.5 kg/m2;
• Bio-impedance phase angle \<5.0°;
• Medium/high nutritional risk according to NRS;
• Any metabolic disorder capable of affecting gluconeogenesis or the ability to adapt to periods of fasting;
• Ongoing treatment with other experimental therapies.

Sponsors & Collaborators

• University of Genova: lead

Study Sites (1)

San Martino Hospital

Genova, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms; Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Alessio Nencioni, MD

  Universita degli Studi di Genova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessio Nencioni, MD

CONTACT

+39 010 353; alessio.nencioni@unige.it

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: Principal Investigator

Model Details: STMF is a 5-day low-calorie and low-protein (totally plant-based) diet that involves a short-term modified fast.

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: March 1, 2023
• Study Start: November 1, 2021
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)