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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

NCT01025167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2010-08-20

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Rainer Fietkau, Prof. Dr. · Department of Radiotherapy University hospital of Erlangen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01025167 on ClinicalTrials.gov