Clinical trial NCT04027478: Can Fasting Decrease the Side Effects of Chemotherapy?
Official title: Can Fasting Decrease the Side Effects of Chemotherapy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy Effect
Chemotherapeutic Toxicity
Fasting
Keywords: fasting
chemotherapy
Lead sponsor: Sutter Health
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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)

* 2 days prior to chemotherapy, Fasting mimicking diet
* 1 day prior to chemotherapy, Fasting mimicking diet
* Day of chemotherapy, Full fasting(water only)
* 1 day after chemotherapy, Fasting mimicking diet
* 2 days after chemotherapy, Fasting mimicking 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.

* 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.

Estimated study duration:

Patient participation is approximately 16 weeks.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* English speaking
* Patients undergoing chemotherapy with Taxol/carboplatin planned for at least 6 cycles
* Willing to comply with diet and tests
* No significant medical problem that would make fasting dangerous (insulin dependent diabetes, history of hypoglycemia)

Exclusion Criteria:

* Insulin dependent diabetes
* Pregnancy
* History of hypoglycemia, or any other medical condition that the treating physician considers not suitable for fasting

Primary outcomes:
measure: Nausea Grade
timeFrame: 16 weeks
Secondary outcomes:
measure: FMD Tolerability as measured by adverse events
timeFrame: 16 weeks
measure: FMD Tolerability as measured by QOL Questionnaire
timeFrame: 16 weeks
measure: Incidence of neutropenia
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
Study officials:
affiliation: Sutter Health
name: Stacy D'Andre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sutter Health
name: Carol Parise, PhD
role: STUDY_DIRECTOR
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