An interventional study of Short-term modified fasting in Cancer, sponsored by University of Genova. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by University of Genova · Not applicable, Interventional, and Other
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.
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
University of Genova is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Effects of the STMF on IGF1 and IGFBP1
IGF1 and IGFBP1 dosage (μg/l)
Time frame: month 1-12
Effects of the STMF on IGFBP3
IGFBP1 dosage (mg/l)
Time frame: 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)
Time frame: month 1-12
Effects of the STMF on insulin
Insulin dosage (mLU/L)
Time frame: month 1-12
Effects of the STMF on adiponectin
Adiponectin dosage (μg/ml)
Time frame: month 1-12
Effects of the STMF on leptin
Leptin dosage (ng/ml)
Time frame: month 1-12
Percentage of prescribed diet consumed and intake of any extra food
It will be assessed using a food diary during 5 days of STMF and is defined as strict adherence to the diet; it is permitted a maximum consumption of 5 Kcal / kg of body weight of extra food on only one of the days of each cycle; or a maximum consumption of 2 Kcal / kg of body weight of extra food in two days of each cycle; or as the reduction of the number of days of the STMF from 5 to 3/4 at most once every three cycles.
Time frame: 3 to 8 weeks depending on the patient's therapy
Quantification of emergent adverse events
It will be assessed monitoring adverse events during STMF according to CTCAE 5.0.
Time frame: 3 to 8 weeks depending on the patient's therapy
Body Weight
Weight is used to calculate the BMI as weight (kg)/height (m2).
Time frame: 3 to 8 weeks depending on the patient's therapy
Effect of STMF on circulating tumor DNA
It will be assessed by measuring circulating tumor DNA - ctDNA
Time frame: month 1-12
Effect of the STMF on the intestinal microbiome
It will be assessed by comparing fecal samples: the investigators are going to collect simples before and after the first and the third cycle. The analysis will be carried out through the analysis of the 16S rRNA present in the sample. The investigators will analyze if and how bacterial strains change in terms of quantity and quantity after cycles of fasting
Time frame: month 1-3
Phase Angle (PA)
PA is a linear method of measuring the relationship between Electrical Resistance (Rz) and Reactance (Xc) both expressed in ohms (Ω). PA is detected by a Single Frequency Bioimpedance Analyzer (BIA 101®, Akern, Florence, Italy). Bioelectrical impedance measurements are subsequently processed with the Bodygram Plus® software (Akern, Florence, Italy). PA is an indicator of nutritional status
Time frame: 3 to 8 weeks depending on the patient's therapy
Handgrip strength
Handgrip strength is evaluated with the use of a dynamometer (T.K.K.5001 GRIP A Hand Grip Analogue Dynamometer, Takei, Japan).
Time frame: 3 to 8 weeks depending on the patient's therapy
Effect of cycles of STMF on leukocyte subpopulations
To evaluate the potential impact of fasting on antitumor immune response, we will use multicolor flow cytometry to explore the frequency of myeloid and lymphocytic peripheral blood mononuclear cell (PBMC) populations, with a particular focus on natural killer (NK) cells (CD45+ CD3- CD56+ CD16+ DR+/-), B cells (CD3-CD45+ CD19+), T cells (CD3+ CD45+), NKT cells (CD45+ CD3+ CD56+ CD16+ DR+/-), helper T (Th) cells (CD3+ CD45+ CD4+ DR+/-), cytotoxic T (CTL) lymphocytes (CD3+ CD45+ CD8+ DR+/-), regulatory T (Treg) cells (CD3+ CD45+ CD8+/- CD4+/- CD127- CD25+), exhausted T cells (CD3+ CD45+ CD8+/- CD4+/- CD28-), activated and effector T cells (CD3+ CD45+ CD8+/- CD4+/- CD39+ CD25+ DR+).
Time frame: month 1-12
Plan to share: No
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