The Effects of Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients: A 2-Arms Pilot Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The effects of short-term fasting and free diet on ovarian cancer
研究概览
简要总结
The primary endpoint of the study is the reduction of insulin levels between the two groups. Using the Student's t-test, while maintaining the study power at 95% and the significance level at 5%, a sample of 27+27 patients will allow the identification of differences in terms of Cohen's d equal to 1.
详细描述
The aim of this study is to investigate the effect of STF on OC patients, receiving NACT. The impact on metabolic and endocrine parameters will be investigated, including Insulin level, in order to correlate IGF-1 values and clinical response rate. In particular, the study aims at investigating the reduction in mean insulin levels among different groups (primary endpoint); the effects of the different dietary regimens on metabolic, endocrine, haematologic, inflammatory and tumoral marker response to NACT, the impact of STF on body weight and body composition, ORR, tolerability and toxicity grade experienced by each patient, PFS, QoL and OS will be investigated as secondary clinical outcomes. As translational endpoints, the study will assess the ability of different dietary regimens to modify the immune system; also, the influence of gut microbiota on the chemotherapeutic regimen and on the immune system status in correlation with dietary approach will be explored. Finally, the correlation of intestinal resection during IDS and thereafter the modulation of gut microbiota will be investigated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18 years or older;
- •Histologically or cytologically documented invasive epithelial OC, primary peritoneal carcinoma, or fallopian tube cancer not suitable for primary cytoreduction, but requiring NACT;
- •FIGO Stage III-IV;
- •No previous treatment for EOC;
- •BMI (Body Mass Index) ≥19 kg/m2;
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-2;
- •Anticipated life expectancy of >3 months;
- •Adequate organ functions:
- •Hematopoietic; Absolute neutrophil count ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3; Hemoglobin ≥ 9 g/Dl
- •Hepatic; AST and ALT ≤ 2.5 times upper limit of normal (ULN)* ; Alkaline Phosphatase ≤ 2.5 times ULN* ; Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 3 times ULN if liver metastases are present
- •Renal: Creatinine Clearance ≥ 45 ml/min or Serum Creatinine ≤1.5 x ULN
- •Serum Albumin >2.5 g/dl;
- •Patients must be accessible for treatment and follow-up;
- •Written informed consent according to the local Ethics Committee requirements
- •Patients with child-bearing potential using (or willing to use) effective contraception during treatment and 3 months ahead unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically
- •Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test
排除标准
- •No other invasive malignancy within the past 5 years;
- •Diabetes mellitus;
- •myocardial infarction, stroke or pulmonary embolism within the last 3 months;
- •Electrocardiogram (ECG) demonstrating clinically significant arrhythmias that are not adequately medically managed (Note: subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible)
- •Active serious systemic disease, including active bacterial or fungal infection
- •Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary
- •heart failure ≥III NYHA
- •Pregnancy or lactating;
- •Significant food allergies which would make the subject unable to consume the food provided;
- •History of or manifest eating disorder;
- •Impaired physical mobility.
研究组 & 干预措施
Short-Term Fasting
Each eligible participant will undergo Short Term Fasting of a total of 60 h during the first three cycles of NACT (36h before and 24h after the end of each cycle of CT).
干预措施: Short Term Fasting (Dietary Supplement)
Free Diet
Patients of this group will be invited to follow with their ordinary diet without any change.
干预措施: Free Diet (Other)
结局指标
主要结局
The effects of short-term fasting and free diet on ovarian cancer
时间窗: At the end of cycle 3 (each cycle is 21 days)
The study primary endpoint is the reduction in mean Insulin (µU/ml) levels among different groups.
次要结局
未报告次要终点
研究者
MARCHETTI CLAUDIA
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS