PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of short-term fasting prior to administration of chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate weight changes in patients who are exposed to short-term fasting prior to chemotherapy.
II. To get a preliminary estimate of the longest feasible fasting period prior to chemotherapy.
III. To evaluate the toxicity profile of systemic chemotherapy treatment in patients who undergo short-term fasting prior to treatment.
IV. To investigate changes in plasma glucose, insulin, IGF-1 and IGF-1BP in patients who undertake short-term fasting.
OUTLINE:
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.
Inclusion
- 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)
- ECOG performance status 0 or 1
- 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
Exclusion
- 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 NYHA grade 2 or more or 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 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
Last updated: 11/07/2012
NCT ID: NCT01175837
IRB Number:10-002451
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