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

NCT ID: NCT05748704

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2025-11-01

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.

Detailed Description

A single-arm phase II clinical trial of a short-term modified fasting regimen (STMF) is proposed to be conducted in 100 patients with solid tumors who are candidates to receive active medical or radiotherapy treatment (or with medical treatment or radiotherapy already ongoing). Cancer treatment can be adjuvant or palliative. Patients with haematological tumors are also included. Enrolment is also foreseen for patients with haematological tumors who are not undergoing active treatment yet, but are followed with a watchful waiting approach (e.g. patients with low-risk B-CLL or low-risk follicular lymphoma). Finally, enrolment is also open to patients with relapsing forms of non-melanoma skin cancers (e.g. basalioma, epithelioma).

The primary endpoint of the study is to evaluate the effects of a STMF on the circulating levels of factors with pro- or anti-oncogenic activity (including insulin, IGF1, IGFBP1, IGFBP3 , leptin, adiponectin, IL-6, TNF-alpha, IL1beta), as well as the effect of STMF cycles on leukocyte subpopulations with a role in the control of tumor growth, such as regulatory T cells, the "myeloid-derived suppressor cells" (MDSC) as well as NK cells, and on stem cell pools (e.g. hematopoietic stem cells, endothelial stem cells, mesenchymal stem cells).

The STMF regimen that is applied is a 5-day low-calorie and low-protein diet. Patients undergo a medical exam/history collection and a nutritional assessment (body weight, handgrip strenght and bioimpedance measurement) at baseline and then at the visits that precede every cycle of STMF (i.e. once every three weeks or monthly, depending on the therapeutic regimen the patient is undergoing, and in any case no more frequently than once every three weeks - eg when combined with q21 chemotherapy regimens). Adverse events are recorded at each visit in accordance with NCI-CTCAE version 5.0. P

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Short-term modified fasting

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).

Group Type: EXPERIMENTAL

Short-term modified fasting

Intervention Type: 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.

Interventions

Short-term modified fasting

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Genova

OTHER

Sponsor Role: lead

Responsible Party

Alessio Nencioni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessio Nencioni, MD

Role: PRINCIPAL_INVESTIGATOR

Universita degli Studi di Genova

Locations

San Martino Hospital

Genova, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessio Nencioni, MD

Role: CONTACT

alessio.nencioni@unige.it

+39 010 353 ext. 1

Facility Contacts

Alessio Nencioni, MD

Role: primary

alessio.nencioni@unige.it

+39 010 353 ext. Ext. 8990

Other Identifiers

STMF

Identifier Type: -

Identifier Source: org_study_id