Can Fasting Decrease the Side Effects of Chemotherapy?
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Sutter Health
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Nausea Grade
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
FMD (fasting-mimicking diet)
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.
Intervention: FMD (Dietary Supplement)
regular diet
Diet not influenced by a fast-mimicking diet.
Outcomes
Primary Outcomes
Nausea Grade
Time Frame: 16 weeks
Grade 2-4 nausea when patients are in the FMD sequence versus the non-fasting sequence
Secondary Outcomes
- FMD Tolerability as measured by QOL Questionnaire(16 weeks)
- Incidence of neutropenia(16 weeks)
- FMD Tolerability as measured by adverse events(16 weeks)
Investigators
Stacy D'Andre, MD
Principal Investigator
Sutter Health