Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

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.

III. Evaluate the toxicity profile of systemic chemotherapy treatment in patients who undergo
short-term fasting prior to treatment.

IV. Investigate changes in plasma glucose, insulin, Insulin-like growth factor 1 (IGF-1) and
IGF-1binding proteins (BP) 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 Criteria:

- 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

Exclusion Criteria:

- 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