Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title:
Study ID: NCT01025167
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO, Bremen, , Germany
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Dresden, Dresden, , Germany
Department of Radiotherapy, University hospital, Erlangen, , Germany
Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Frankfurt, Frankfurt, , Germany
Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Göttingen, Göttingen, , Germany
Klinik für Strahlentherapie, Universitätsklinikum Halle, Halle, , Germany
Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes, Homburg (Saar), , Germany
Klinik und Poliklinik für Strahlentherapie Universität Rostock, Rostock, , Germany
Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Tübingen, Tübingen, , Germany
Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Ulm, Ulm, , Germany
Contact Details
Name: Rainer Fietkau, Prof. Dr.
Affiliation: Department of Radiotherapy University hospital of Erlangen
Role: PRINCIPAL_INVESTIGATOR
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