Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study
I. To assess the safety and feasibility of short-term fasting prior to administration of
I. To evaluate weight changes in patients who are exposed to short-term fasting prior to
II. To get a preliminary estimate of the longest feasible fasting period prior to
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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Safety and feasibility of short-term fasting prior to administration of chemotherapy as assessed by number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications)
At 24, 36, and 48 hours
Roxana S Dronca, M.D.
United States: Institutional Review Board
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