An interventional study of FMD in Chemotherapy Effect, Chemotherapeutic Toxicity and Fasting, sponsored by Sutter Health. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-22.
Sponsored by Sutter Health · Not applicable, Interventional, and Supportive care
This is a prospective randomized crossover trial. Patients will be randomized to the FMD or regular diet during three rounds of chemotherapy. After the third round, patients will cross over to the opposite arm. The primary hypothesis is that there will be fewer cases of Grade 2-4 nausea when patients are in the FMD sequence. The primary objective is to assess differences in toxicities in patients undergoing chemotherapy with a combination of taxol/carboplatin when using a fasting mimicking diet when compared to normal diet before and after treatment.
Randomization and blinding:
Subjects will be allocated to sequence 1 (normal diet first, FMD second) or sequence 2 (FMD first, normal diet second) using a computer generated randomization scheme. There will be no blinding
Intervention:
Over the course of three rounds of chemotherapy, patients in the FMD will consume a diet that consists of 10 cal/kg/day and includes 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners. Patients will be instructed to drink 2 cups of water each morning, take their usual medications and limit exercise to walking.
The table below provides the schedule of fasting during the cycle of chemotherapy
(Time during chemotherapy cycle, Diet)
Prior to each chemotherapy cycle and coincident FMD arm, weight, and laboratory testing will be conducted and patients will be asked to keep track of side effects as per usual care for patients undergoing chemotherapy. Patients will be asked to keep a food log and record the quality of their sleep as part of the study.
There will be no restrictions for use of usual standard medications, including anti-nausea medication. This is generally Zofran oral, q8 hours PRN. Anti-nausea medication usage will be recorded in the study database. Although it is expected to be consistent throughout the diet and control periods for each subject, dosage and frequency will be recorded throughout the study, and it will be noted if anti-nausea medication is effective during the control period for each subject.
Endpoint evaluation:
Severity of AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for toxicity and adverse event reporting. A copy of the CTCAE Version 3.0 can be downloaded from https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf.
AEs not corresponding to the CTCAE term will be assessed according to their impact on the subject's ability to perform daily activities as follows:
Mild (grade 1) - the AE does not interfere in a significant manner with the subject's normal functioning level. It may be an annoyance.
Estimated study duration:
Patient participation is approximately 16 weeks.
87 studies on the registry are indexed under Fasting; 38 are open to participants now.
This study's planned enrollment of 39 is below the median of 60 across 66 interventional studies indexed under Fasting.
Browse Fasting studies →Sutter Health is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Over the course of three rounds of chemotherapy, patients in the FMD will consume a diet that consists of 10 cal/kg/day and includes 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners. Patients will be instructed to drink 2 cups of water each morning, take their usual medications and limit exercise to walking.
Dietary Supplement: FMD
Diet not influenced by a fast-mimicking diet.
fasting mimicking diet
Nausea Grade
Grade 2-4 nausea when patients are in the FMD sequence versus the non-fasting sequence
Time frame: 16 weeks
FMD Tolerability as measured by adverse events
Severity of AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for toxicity and adverse event reporting. AEs not corresponding to the CTCAE term will be assessed according to their impact on the subject's ability to perform daily activities as follows: * Mild (grade 1) - the AE does not interfere in a significant manner with the subject's normal functioning level. It may be an annoyance. * Moderate (grade 2) - the AE produces some impairment of functioning, but is not hazardous to health. It is uncomfortable or an embarrassment. * Severe (grade 3) - the AE produces significant impairment of functioning or incapacitation and is a definite hazard to the subject's health. * Life threatening (grade 4) - Life threatening or disabling. * Fatal (grade 5) - Causes death of the participant.
Time frame: 16 weeks
FMD Tolerability as measured by QOL Questionnaire
Mean differences in QOL between patients during the FMD versus normal diet sequence will be measured using a repeated measures analysis of variance. QOL questionnaire used will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire.
Time frame: 16 weeks
Incidence of neutropenia
Differences in neutropenia between patients during the FMD versus normal diet sequence
Time frame: 16 weeks
Start is estimated for Sep 2019; primary completion for Aug 2020, 11 months later.
Of 42 non-industry interventional studies with no phase under Fasting, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 11 months is below that.
Counting every sponsor, half of 43 studies reached it within 31 months; a quarter within 10 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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