NCT01175837

Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	questionnaire administration	Ancillary studies: Pre- and post-fasting side effect questionnaires
OTHER	preventative dietary intervention	24, 36, or 48 hour fast prior to chemotherapy
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-08-13
• Primary completion: 2013-05-02
• Completion: 2018-12-10
• First posted: 2010-08-05
• Last updated: 2018-12-12

Locations

1 site across 1 country: United States