Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborator:
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Studienlocations (1 von 1)
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg 91052 Erlangen (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Yurdaguel Zopf, Prof. Dr. med. Phone: +49 9131 85-45218 E-Mail: yurdaguel.zopf@uk-erlangen.de
Hans Joachim Herrmann, Dr. oec. troph. Phone: +49 9131 85-45017 E-Mail: hans.herrmann@uk-erlangen.de» Ansprechpartner anzeigen
This study evaluates if a novel form of oral nutritional Supplement application in the form
of gumdrops may serve as an alternative to common sip Feeds in cancer patients with high risk
for malnutrition. Within this context the Impact of these two different supplements on
General condition, Quality of life, muscle function, Body composition, Appetite and Nutrition
Status are investigated. Patients are randomly allocated either to a study group with oral
Supplementation in the form of sip feed or to a study Group receiving gumdrops for 4 weeks.
After a washout period of 5-7 days study Groups are switched for another 4 week Intervention
period.
1. Compliance (Time Frame - 4 weeks): compliance of nutritional supplement intake assessed by Medication Adherence Report Scale (MARS-D); Total score ranges from 0-10 with a higher score indicating better adherence
2. Tolerance of the form of oral supplementation (Time Frame - 4 weeks): assessment of hedonic and sensoric estimation of oral supplements by questionnaire
Secondary outcome:
1. Body weight (Time Frame - 4 weeks): Body weight assessed by bioelectrical impedance analysis (in kg)
2. Body composition (Time Frame - 4 weeks): Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg)
3. Physical function - Isometric muscle strength (Time Frame - 4 weeks): Hand grip strength assessed by hand dynamometer (in kg)
4. Physical function - Lower limb strength (Time Frame - 4 weeks): 30 second sit-to-stand test (number of sit-to-stand cycles)
5. Physical function - Endurance (Time Frame - 4 weeks): Six-minute-walk test (walking distance in m)
6. Patient-reported performance status (Time Frame - 4 weeks): ECOG performance status/Karnofsky index
7. subjective Physical activity (Time Frame - 4 weeks): Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ)
