CancerNCT03595540
Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment
A study testing Prolon in people with Cancer and Breast Cancer, run by University of Genova at 1 site in Italy.
Trial summary
This is a pilot, single arm prospective trial assessing feasibility, safety and effects on patient nutritional status of a 5-day fasting-mimicking diet (FMD) in patients with different cancer types and concomitant anticancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- Prolon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2017to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age > 18 years
- Patients with solid or hematologic tumors undergoing active treatment, including patients who are preparing to start a new treatment with chemotherapeutic regimens, hormone therapies, other molecularly targeted therapies (including kinase inhibitors), biologics (including trastuzumab) , pertuzumab, cetuximab and bevacizumab) or inhibitors of immune checkpoints (eg Opdivo, Keytruda), ie patients in whom treatment is already underway;
- ECOG performance status 0-1
- Adequate organ function
- BMI >21 kg/m2 (with possibility to also enroll patients with 19<BMI<21 based on the judgement of the treating physician)
- Low nutritional risk according to nutritional risk screening (NRS)
Who cannot join
- Diabetes mellitus;
- Previous therapy with IGF-1 inhibitors;
- Food allergies to the components of the FMD;
- BMI <19 kg/m2;
- bio-impedance phase angle <5.0°;
- medium/high nutritional risk according to NRS;
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- Any metabolic disorder that can affect gluconeogenesis or ability to adapt to fasting periods;
- Patients who live alone or are not adequately supported by the family context;
- Treatment in progress with other experimental therapies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Study of a Fasting-mimicking Diet in Patients Undergoing Oncologic Treatment
This is a pilot, single arm prospective trial assessing feasibility, safety and effects on patient nutritional status of a 5-day fasting-mimicking diet (FMD) in patients with different cancer types and concomitant anticancer treatment.
Read the detailed description
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.
- Conditions
- Cancer, Breast Cancer, Colorectal Cancer
- Being tested
- Prolon
- Keywords
- fasting-mimicking diet, cancer, nutritional status, body composition, fasting
- Medical subject headings
- Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlonOther
Also called fasting-mimicking diet
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.
| Study group | Role | What they receive |
|---|---|---|
| Prolon - FMD | Experimental | Patients undergoing active cancer treatment are assigned monthly cycles of the fasting-mimicking diet Prolon Receives: Other: Prolon |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of prescribed diet consumed and intake of any extra food
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.
Measured: 6 months
Quantification of FMD-emergent adverse events
The side effects of Prolon (hematologic and non-hematologic) will be classified according to NCI CTCAE 5.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start22 Nov 2017
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Nencioni, University of Genova
- Investigators
- Alessio Nencioni, MD, Principal investigator, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595540
- Sponsor's protocol ID
- 308CER2017
- Status last verified
- Oct 2022
- First submitted
- 12 Jul 2018
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valdemarin F, Caffa I, Persia A, Cremonini AL, Ferrando L, Tagliafico L, Tagliafico A, Guijarro A, Carbone F, Ministrini S, Bertolotto M, Becherini P, Bonfiglio T, Giannotti C, Khalifa A, Ghanem M, Cea M, Sucameli M, Murialdo R, Barbero V, Gradaschi R, Bruzzone F, Borgarelli C, Lambertini M, Vernieri C, Zoppoli G, Longo VD, Montecucco F, Sukkar SG, Nencioni A. Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment. Cancers (Basel). 2021 Aug 9;13(16):4013. doi: 10.3390/cancers13164013.
PubMed 34439167
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of a Fasting-mimicking Diet in Patients Undergoing Oncologic Treatment
- ClinicalTrials.gov ID
- NCT03595540
- Acronym / sponsor ID
- 308CER2017
- Conditions
- Cancer, Breast Cancer, Colorectal Cancer
- Keywords
- fasting-mimicking diet, cancer, nutritional status, body composition, fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot, single arm prospective trial assessing feasibility, safety and effects on patient nutritional status of a 5-day fasting-mimicking diet (FMD) in patients with different cancer types and concomitant anticancer treatment.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prolon - FMD | Experimental | Other: ProlonPatients undergoing active cancer treatment are assigned monthly cycles of the fasting-mimicking diet Prolon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent
- Age > 18 years
- Patients with solid or hematologic tumors undergoing active treatment, including patients who are preparing to start a new treatment with chemotherapeutic regimens, hormone therapies, other molecularly targeted therapies (including kinase inhibitors), biologics (including trastuzumab) , pertuzumab, cetuximab and bevacizumab) or inhibitors of immune checkpoints (eg Opdivo, Keytruda), ie patients in whom treatment is already underway;
- ECOG performance status 0-1
- Adequate organ function
Key exclusion criteria (9 listed)
- Diabetes mellitus;
- Previous therapy with IGF-1 inhibitors;
- Food allergies to the components of the FMD;
- BMI <19 kg/m2;
- bio-impedance phase angle <5.0°;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProlonAlso: fasting-mimicking dietProlon 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 | Prolon - FMD |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Derived from this study: PubMed 34439167Valdemarin F, Caffa I, Persia A, Cremonini AL, Ferrando L, Tagliafico L, Tagliafico A, Guijarro A, Carbone F, Ministrini S, Bertolotto M, Becherini P, Bonfiglio T, Giannotti C, Khalifa A, Ghanem M, Cea M, Sucameli M, Murialdo R, Barbero V, Gradaschi R, Bruzzone F, Borgarelli C, Lambertini M, Vernieri C, Zoppoli G, Longo VD, Montecucco F, Sukkar SG, Nencioni A. Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment. Cancers (Basel). 2021 Aug 9;13(16):4013. doi: 10.3390/cancers13164013.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessio Nencioni, MD principal investigator
Universita degli Studi di Genova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolon in people with Cancer and Breast Cancer, run by University of Genova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of prescribed diet consumed and intake of any extra food (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.