Can Fasting Decrease the Side Effects of Chemotherapy?
试验速览
- 阶段
- 不适用
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Nausea Grade
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Insulin dependent diabetes
- •Pregnancy
- •History of hypoglycemia, or any other medical condition that the treating physician considers not suitable for fasting
研究组 & 干预措施
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.
干预措施: FMD (Dietary Supplement)
regular diet
Diet not influenced by a fast-mimicking diet.
结局指标
主要结局
Nausea Grade
时间窗: 16 weeks
Grade 2-4 nausea when patients are in the FMD sequence versus the non-fasting sequence
次要结局
- FMD Tolerability as measured by QOL Questionnaire(16 weeks)
- Incidence of neutropenia(16 weeks)
- FMD Tolerability as measured by adverse events(16 weeks)
研究者
Stacy D'Andre, MD
Principal Investigator
Sutter Health