Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment
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|ClinicalTrials.gov Identifier: NCT03595540|
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Breast Cancer Colorectal Cancer||Other: Prolon||Not Applicable|
It is proposed to conduct a single-arm phase II clinical study of a FMD (Prolon, by L-Nutra) in 60 patients with solid or hematologic tumors who undergo treatment with chemotherapeutic regimens, hormone therapies, other molecularly targeted therapies (including kinase inhibitors), biological drugs (including trastuzumab, pertuzumab, cetuximab and bevacizumab) or inhibitors of immune checkpoints (e.g. Opdivo, Keytruda).
Prolon is a FMD lasting five days. It consist of vegetable soups, broths, bars, olives, crackers, herbal teas, supplements of vitamins and minerals. Day 1 of the FMD supplies ~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.
Primary endpoints of the study are the feasibility and safety of monthly cycles of the FMD in patients with solid or hematologic tumors who undergo active treatment. Feasibility is 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 of admitting the consumption of only 50% of the planned diet and / or a maximum consumption of 4-5 Kcal / kg body weight of food not provided in only one of the five days of each cycle. Furthermore, the dosage of IGF-1 and of urinary ketone bodies allow to identify further cases of non-adherence to the diet.
FMD-emergent side effects are monitored according to the NCI-CTCAE version 5.0.
Secondary endpoints include:
- patient nutritional status as monitored by weight, handgrip strength, bio-impedance and serum markers (ferritin, transferrin, colinesterase).
- Quality of life (QLQ-C30)
- Clinical responses measured by CT, MRI or by blood chemistry tests, dosing of tumor markers and / or molecular biology tests in the case of prostate tumors or hematologic tumors (e.g. PSA in patients affected by prostate cancer, BCR / Abl mRNA in the case of patients undergoing treatment with kinase inhibitors for CML; CM in the case of patients undergoing treatment for multiple myeloma).
- Long-term efficacy (progression-free survival, overall survival).
- Effect of FMD on HOMA index, PCR, circulating levels of IGF-1 and urinary levels of ketone bodies.
- Effect of FMD on lymphocyte subsets, NK cells and antigen-presenting cells with a role documented in antitumor immunity.
It is foreseen that 60 patients will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Study of a Fasting-mimicking Diet in Patients Undergoing Oncologic Treatment|
|Actual Study Start Date :||November 22, 2017|
|Estimated Primary Completion Date :||April 15, 2020|
|Estimated Study Completion Date :||September 14, 2020|
Experimental: Prolon - FMD
Patients undergoing active cancer treatment are assigned monthly cycles of the fasting-mimicking diet Prolon
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.
Other Name: fasting-mimicking diet
- percentage of prescribed diet consumed and intake of any extra food [ Time Frame: 6 months ]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.
- Quantification of FMD-emergent adverse events [ Time Frame: 6 months ]The side effects of Prolon (hematologic and non-hematologic) will be classified according to NCI CTCAE 5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595540
|Contact: Alessio Nencioni, MD||+39 010 353 ext email@example.com|
|Genoa, GE, Italy, 16132|
|Contact: Alessio Nencioni, MD +39 010 353 ext 8990 firstname.lastname@example.org|
|Principal Investigator:||Alessio Nencioni, MD||University of Genoa|