Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment (NCT03595540) | Clinical Trial Compass
CompletedNot Applicable
Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment
Italy90 participantsStarted 2017-11-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion criteria:
* 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;
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
percentage of prescribed diet consumed and intake of any extra food