NCT01025167

The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the impact of a specific nutrition formula with a high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving radio-/chemotherapy on body weight, body composition, nutritional status and physical function compared to a standard nutrition formula. Using an adaptive design approximately 80 patients will be randomized in the first part of the study. Following an interim analysis further 160 patients may be added, for a total of 240 patients.

Conditions

• Enteral Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)	500 ml per day / treatment period 11-14 weeks
DIETARY_SUPPLEMENT	Fresubin(R)	500 ml/a nutritionally complete enteral standard feed (isoenergetic)

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-12-03
• Last updated: 2010-08-20

Locations

10 sites across 1 country: Germany