Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Fasting before chemotherapy may protect normal cells from the side effects of chemotherapy.

PURPOSE: This clinical trial studies short-term fasting before chemotherapy in treating patients with cancer.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

Roxana S Dronca, M.D.

Study Chair

U.S.A.
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Mayo Clinic Clinical Trials Office	Ph: 507-538-7623
		Roxana S Dronca, M.D.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01175837
Information obtained from ClinicalTrials.gov on November 20, 2012

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