Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

Malignant Neoplasm Clinical Trial

Official title: Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study

Status Completed

Clinical Trial Summary

This clinical trial studies short-term fasting before chemotherapy in treating patients with cancer. Fasting before chemotherapy may protect normal cells from the side effects of chemotherapy.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

• NCT number: NCT01175837
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: N/A
• Start date: August 13, 2010
• Completion date: December 10, 2018