Clinical Trials

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.