Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period
研究概览
简要总结
This clinical trial studies short-term fasting before chemotherapy in treating patients with cancer. Fasting before chemotherapy may protect normal cells from the side effects of chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. Assess the safety and feasibility of short-term fasting prior to administration of chemotherapy.
SECONDARY OBJECTIVES:
I. Evaluate weight changes in patients who are exposed to short-term fasting prior to chemotherapy.
II. Get a preliminary estimate of the longest feasible fasting period prior to chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed malignancy
- •Scheduled to undergo 4 or more cycles of chemotherapy (with or without past chemotherapy treatment); NOTE: Acceptable chemotherapy regimens are those that have all drugs infused on the first day of the chemotherapy cycle over a period =< 8 hours; EXCEPTION: Continuous 5-FU-containing regimens (such as FOLFOX6 and FOLFIRI) are allowed as both the 5-FU bolus as well as the oxaliplatin and irinotecan administration is completed on day 1 of chemotherapy
- •Life expectancy of >= 168 days (6 months)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Body mass index (BMI) > 21 kg/m^2
- •Weight loss < 5% of body weight in the last 168 days (6 months)
- •Adequate renal function (serum creatinine < 1.5 X UNL [upper normal limit] or creatinine clearance > 50 ml/min)
- •Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- •Provide informed consent
- •Ability to complete patient booklet by themselves or with assistance
- •Ability and willingness to undergo >= 24-hour fast prior to chemotherapy
- •Willingness to be treated at Mayo Clinic Rochester and be available for follow-up
- •Patient willing to provide blood samples for correlative research purposes
排除标准
- •Any of the following:
- •Pregnant women;
- •Nursing women;
- •Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study period
- •Diabetes mellitus undergoing therapy with insulin or oral agents
- •History of low serum glucose (hypoglycemia) or insulinoma
- •History of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous
- •On daily medication that may not be safely taken without food; NOTE: Any non-essential medications and herbal/vitamin supplements should be held to minimize stomach upset during fasting; vitamin C use is discouraged
- •Active gastric or duodenal peptic ulcer disease
- •History of significant cardiac disease, particularly uncompensated congestive heart failure New York Heart Association (NYHA) grade 2 or more or left ventricular ejection fraction (LVEF) < 40% on any prior assessment; NOTE: Assessment of LVEF prior to therapy is not required in the absence of other clinical indicators of heart disease
- •Recent history (< 6 months) of cerebrovascular accident or transient ischemic attacks
- •History of gout or elevated uric acid level
- •Psychiatric conditions that preclude adherence to study protocol
- •Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled or whose control may potentially be jeopardized by the complications of fasting
- •Patients receiving parenteral nutrition
- •Receiving steroids (except dexamethasone given for nausea prevention before chemotherapy)
- •Patients receiving taxotere-containing chemotherapy regimens requiring pre-treatment steroid administration
- •Receiving concomitant treatment with insulin-like growth factor (IGF)-receptor blockers or monoclonal antibodies targeting the IGF ligands
- •Any of the following (prior to registration):
- •=< 7 days from the time of a minor surgery;
- •=< 21 days from the time of major surgery;
- •=< 21 days from the time of radiation therapy
- •Currently enrolled in a concomitant clinical trial
研究组 & 干预措施
Short-term fasting prior to systemic chemotherapy
COHORT I: Patients fast 24 hours before day 1 of course 2 of chemotherapy. If fast is well tolerated, patients may escalate fasting by 12 hours for each subsequent course of chemotherapy for up to 3 courses in the absence of unacceptable toxicity.
COHORT II: Patients fast at the longest fasting regimen found to be safe and tolerable in cohort I before day 1 of each course of course of chemotherapy for up to 4 courses in the absence of unacceptable toxicity.
干预措施: questionnaire administration (Other)
Short-term fasting prior to systemic chemotherapy
COHORT I: Patients fast 24 hours before day 1 of course 2 of chemotherapy. If fast is well tolerated, patients may escalate fasting by 12 hours for each subsequent course of chemotherapy for up to 3 courses in the absence of unacceptable toxicity.
COHORT II: Patients fast at the longest fasting regimen found to be safe and tolerable in cohort I before day 1 of each course of course of chemotherapy for up to 4 courses in the absence of unacceptable toxicity.
干预措施: preventative dietary intervention (Other)
Short-term fasting prior to systemic chemotherapy
COHORT I: Patients fast 24 hours before day 1 of course 2 of chemotherapy. If fast is well tolerated, patients may escalate fasting by 12 hours for each subsequent course of chemotherapy for up to 3 courses in the absence of unacceptable toxicity.
COHORT II: Patients fast at the longest fasting regimen found to be safe and tolerable in cohort I before day 1 of each course of course of chemotherapy for up to 4 courses in the absence of unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period
时间窗: Up to 48 hours
Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications)
时间窗: Up to 48 hours
Percentage of patients able to achieve designated fasting regimen (i.e., greater than or equal to 50%)
时间窗: Up to 48 hours
次要结局
- Overall toxicity incidence and profiles by fasting time and patient as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0(4 months)
- Changes in levels of plasma glucose, insulin, IGF-1 and IGF-1BP in subjects who undertake short-term fasting by descriptive statistics(Baseline and 4 months)
- Weight changes in patients who are exposed to short-term fasting prior to chemotherapy(Baseline and 4 months)
- Change in toxicity as assessed by Side Effect Questionnaire and descriptive statistics(Baseline and 4 months)
- Frequency and percentage of the longest feasible fasting period prior to chemotherapy(4 months)