Short-Term Fasting Prior To Platinum-based Chemotherapy: Feasibility and Impact on Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Identification of the longest duration of fasting which is safe
研究概览
简要总结
This partially randomized clinical trial studies short-term fasting in reducing side effects in patients receiving gemcitabine hydrochloride and cisplatin for advanced solid tumors. Short-term fasting before chemotherapy may reduce the side effects caused by chemotherapy. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
详细描述
OBJECTIVES:
I. To determine the safety and feasibility of short-term fasting prior to administration of combination chemotherapy with platinum in patients with advanced solid tumor malignancies.
II. To evaluate the toxicity profile of platinum-based chemotherapy in subjects who eat normally compared to those who undertake short-term starvation.
III. To investigate changes in plasma insulin, glucose, IGF1 and IGF binding protein (IGFBP) levels, and oxidative stress markers in subjects who undertake short-term fasting compared to controls.
IV. To investigate whether changes in grp78 expression occur after fasting and after chemotherapy administration in human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Histologically confirmed malignancy for which platinum-based chemotherapy on a 21 day cycle or 14 day cycle is being recommended.
- •Disease state:
- •Stage I of the trial: newly diagnosed disease for which neoadjuvant or adjuvant chemotherapy is planned in the curative setting, or metastatic disease.
- •Stage II of the trial: Measurable disease by RECIST criteria must be present for all subjects in the randomized component of the trial- if surgery or radiation is planned, the target lesions may not be so treated until after the assessment of the effect of chemotherapy.
- •Prior chemotherapy
- •Stage I: subjects may have already received no more than 2 cycle of platinum-based chemotherapy, but should not have received other prior chemotherapy regimens with the exception of patients with metastatic disease who received neoadjuvant or adjuvant chemotherapy and that chemotherapy was completed > 6 months prior to enrollment.
- •Stage II: subjects must have received no prior chemotherapy regimens for metastatic disease, and no more than 2 cycles of their current platinum chemotherapy regimen for metastatic disease. They may have received prior neoadjuvant or adjuvant chemotherapy, provided such therapy was completed >6 months prior to enrollment.
- •Prior Radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment.
- •BMI > 18.5
- •ECOG performance status 0-1
- •Adequate renal function (Creatinine <1.25 ULIN or calculated creatinine clearance > 50 ml/min)
- •Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period.
排除标准
- •Diabetes Mellitus
- •Recent significant or unexplained weight loss that the investigator feels may pose an unacceptable risk for enrollment. Candidates who are overweight and have lost weight intentionally via diet or exercise should not be excluded.
- •Peripheral Neuropathy > grade 1
- •History of significant cardiac disease, particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF < 40% on any prior assessment. (Assessment of LVEF prior to therapy is not required in the absence of other clinical indicators of heart disease). Patients with a prior LVEF <40% will require re-evaluation prior to study entry.
- •Subjects on medications that may not be safely stopped during the fasting portion of the study, or which may not be safely consumed without food.
- •A history of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous.
研究组 & 干预措施
Group I (Stage I of study)
Patients fast for 24 hours on day -1
干预措施: Short-term fasting (Other)
Group I (Stage I of study)
Patients fast for 24 hours on day -1
干预措施: Fasting (Other)
Group II (Stage I of study)
Patients fast for 48 hours on days -2 and -1
干预措施: Short-term fasting (Other)
Group II (Stage I of study)
Patients fast for 48 hours on days -2 and -1
干预措施: Fasting (Other)
Group III (Stage I of study)
Patients fast for 72 hours on days -3, -2, and -1
干预措施: Short-term fasting (Other)
Group III (Stage I of study)
Patients fast for 72 hours on days -3, -2, and -1
干预措施: Fasting (Other)
Group IV (Stage I of study)
Patients undergo a modified 48-hour fast with minimal caloric intake on day -2 and -1
干预措施: Modified fast (Other)
Group IV (Stage I of study)
Patients undergo a modified 48-hour fast with minimal caloric intake on day -2 and -1
干预措施: Fasting (Other)
结局指标
主要结局
Identification of the longest duration of fasting which is safe
时间窗: Up to 5 years
次要结局
- Changes in plasma insulin, glucose, IGF1 and IGF binding protein (IGFBP) levels, and GRP78 expression in WBCs(Up to 2 courses)
- Significant toxicity as assessed by CTCAE v3.0(Up to 5 years)
- Changes in grp78 expression after fasting and after chemotherapy administration(After 2 courses)