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

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

NCT ID: NCT05748704

Condition: Cancer

Conditions: Keywords:
fasting
short-term modified fasting

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

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

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Short-term modified fasting
Description: 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.
Arm group label: Short-term modified fasting

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

Criteria for 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 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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: San Martino Hospital

Address:
City: Genova
Zip: 16132
Country: Italy

Status: Recruiting

Contact:
Last name: Alessio Nencioni, MD

Phone: +39 010 353

Phone ext: Ext. 8990
Email: alessio.nencioni@unige.it

Start date: November 1, 2021

Completion date: November 1, 2025

Lead sponsor:
Agency: University of Genova
Agency class: Other

Source: University of Genova

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05748704