NCT02607826

Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 298 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recent pre-clinical data provide strong evidence that short-term starvation before the administration of cytostatic drugs for the chemotherapy of solid tumors leads to significantly higher efficacy and lower toxicity levels. However, these findings have so far not been validated in patients. The aim of this trial is to provide first clinical evidence regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy (primary endpoint). Additionally, progression-free survival, adverse events, and overall survival will be monitored (secondary endpoints). In perspective, short-term starvation before chemotherapy could represent a simple and secure way to improve both efficacy and tolerance of chemotherapies at low cost.

Conditions

• Cholangiocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Colorectal Cancer
• Gastric Cancer
• Adenocarcinoma of the Esophagogastreal Junction
• Esophagus Cancer

Interventions

Type	Name	Description
PROCEDURE	Starvation	Short-term starvation for a timeframe beginning 24h prior to chemotherapy administration, lasting until 6h after administration

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2015-11-18
• Last updated: 2016-10-28