Phase II Clinical Study of a Fasting-mimicking Diet in Patients Undergoing Oncologic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- percentage of prescribed diet consumed and intake of any extra food
研究概览
简要总结
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.
详细描述
It is proposed to conduct a single-arm phase II clinical study of a FMD (Prolon, by L-Nutra) in 60 patients with solid or hematologic tumors who undergo treatment with chemotherapeutic regimens, hormone therapies, other molecularly targeted therapies (including kinase inhibitors), biological drugs (including trastuzumab, pertuzumab, cetuximab and bevacizumab) or inhibitors of immune checkpoints (e.g. Opdivo, Keytruda).
Prolon is a FMD lasting five days. It consist of vegetable soups, broths, bars, olives, crackers, herbal teas, supplements of vitamins and minerals. Day 1 of the FMD supplies ~4600 kJ (11% protein, 46% fat, and 43% carbohydrate), whereas days 2-to-5 provide ~3000 kJ (9% protein, 44% fat, and 47% carbohydrate) per day.
Primary endpoints of the study are the feasibility and safety of monthly cycles of the FMD in patients with solid or hematologic tumors who undergo active treatment. Feasibility is monitored through the compilation of a food diary and is defined as the strict adherence to the diet prescribed in all its days with the possibility of admitting the consumption of only 50% of the planned diet and / or a maximum consumption of 4-5 Kcal / kg body weight of food not provided in only one of the five days of each cycle. Furthermore, the dosage of IGF-1 and of urinary ketone bodies allow to identify further cases of non-adherence to the diet.
FMD-emergent side effects are monitored according to the NCI-CTCAE version 5.0.
Secondary endpoints include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •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.
排除标准
- 未提供
结局指标
主要结局
percentage of prescribed diet consumed and intake of any extra food
时间窗: 6 months
Feasibility will be monitored through the compilation of a food diary and is defined as the strict adherence to the diet prescribed in all its days with the possibility to admit the consumption of only 50% of the planned diet and / or a maximum consumption of 4- 5 Kcal / kg of food not expected in only one of the days -2, -1, +1 of each cycle.
Quantification of FMD-emergent adverse events
时间窗: 6 months
The side effects of Prolon (hematologic and non-hematologic) will be classified according to NCI CTCAE 5.0
次要结局
未报告次要终点
研究者
Alessio Nencioni
Associate Professor
University of Genova