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Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
Rochester, MN
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Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
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.
NCT ID:
NCT01175837IRB Number:
10-002451Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
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