Phase I / II Single Arm Study: Metabolic and Immunological Effects of a Modified Fasting Regimen in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effects of the STMF on IGF1 and IGFBP1
研究概览
简要总结
This is a single-arm prospective pilot study assessing the metabolic and immunologic effects of a modified fasting regimen in cancer patients with different cancer types and concomitant anticancer treatment.
详细描述
A single-arm phase II clinical trial of a short-term modified fasting regimen (STMF) is proposed to be conducted in 100 patients with solid tumors who are candidates to receive active medical or radiotherapy treatment (or with medical treatment or radiotherapy already ongoing). Cancer treatment can be adjuvant or palliative. Patients with haematological tumors are also included. Enrolment is also foreseen for patients with haematological tumors who are not undergoing active treatment yet, but are followed with a watchful waiting approach (e.g. patients with low-risk B-CLL or low-risk follicular lymphoma). Finally, enrolment is also open to patients with relapsing forms of non-melanoma skin cancers (e.g. basalioma, epithelioma).
The primary endpoint of the study is to evaluate the effects of a STMF on the circulating levels of factors with pro- or anti-oncogenic activity (including insulin, IGF1, IGFBP1, IGFBP3 , leptin, adiponectin, IL-6, TNF-alpha, IL1beta), as well as the effect of STMF cycles on leukocyte subpopulations with a role in the control of tumor growth, such as regulatory T cells, the "myeloid-derived suppressor cells" (MDSC) as well as NK cells, and on stem cell pools (e.g. hematopoietic stem cells, endothelial stem cells, mesenchymal stem cells).
The STMF regimen that is applied is a 5-day low-calorie and low-protein diet. Patients undergo a medical exam/history collection and a nutritional assessment (body weight, handgrip strenght and bioimpedance measurement) at baseline and then at the visits that precede every cycle of STMF (i.e. once every three weeks or monthly, depending on the therapeutic regimen the patient is undergoing, and in any case no more frequently than once every three weeks - eg when combined with q21 chemotherapy regimens). Adverse events are recorded at each visit in accordance with NCI-CTCAE version 5.0. P
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 65 Years（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 chemotherapy regimens, hormone therapies, other molecularly targeted therapies - including kinase inhibitors, biologicals or inhibitors of immune checkpoints; patients in whom treatment is already ongoing are also eligible; patients with haematological malignancies who are managed by watchful waiting (e.g. low-risk B-CLL or follicular lymphoma) as well as patients with relapsing forms of non-melanoma skin cancer (basal or squamous cell carcinoma) are also eligible.
- •ECOG performance status 0-1
- •Adequate organ function
- •BMI >21 kg/m2 (with possibility to also enroll patients with 18.5<BMI<21 based on the judgement of the treating physician)
- •Low nutritional risk according to nutritional risk screening (NRS)
排除标准
- •Age> 65 years [with the possibility to enroll from 65 to 75 years old patients if considered safe by the examining doctor
- •Diabetes mellitus;
- •BMI <18.5 kg/m2;
- •Bio-impedance phase angle <5.0°;
- •Medium/high nutritional risk according to NRS;
- •Any metabolic disorder capable of affecting gluconeogenesis or the ability to adapt to periods of fasting;
- •Ongoing treatment with other experimental therapies.
结局指标
主要结局
Effects of the STMF on IGF1 and IGFBP1
时间窗: month 1-12
IGF1 and IGFBP1 dosage (μg/l)
Effects of the STMF on IGFBP3
时间窗: month 1-12
IGFBP1 dosage (mg/l)
Effects of the STMF on Interleukin-6 (IL-6), interleukin-1 beta (IL1-beta) and tumor necrosis factor-alpha (TNF-alpha)
时间窗: month 1-12
IL-6, IL-1beta and TNF-alpha dosage (pg/ml)
Effects of the STMF on adiponectin
时间窗: month 1-12
Adiponectin dosage (μg/ml)
Effects of the STMF on leptin
时间窗: month 1-12
Leptin dosage (ng/ml)
Effects of the STMF on insulin
时间窗: month 1-12
Insulin dosage (mLU/L)
次要结局
- Effect of STMF on circulating tumor DNA(month 1-12)
- Effect of the STMF on the intestinal microbiome(month 1-3)
- Phase Angle (PA)(3 to 8 weeks depending on the patient's therapy)
- Percentage of prescribed diet consumed and intake of any extra food(3 to 8 weeks depending on the patient's therapy)
- Quantification of emergent adverse events(3 to 8 weeks depending on the patient's therapy)
- Body Weight(3 to 8 weeks depending on the patient's therapy)
- Handgrip strength(3 to 8 weeks depending on the patient's therapy)
- Effect of cycles of STMF on leukocyte subpopulations(month 1-12)
研究者
Alessio Nencioni
Principal Investigator
University of Genova