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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
normal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein)
normal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein)
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, Germany
RECRUITINGCompliance
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
Time frame: 4 weeks
Tolerance of the form of oral supplementation
assessment of hedonic and sensoric estimation of oral supplements by questionnaire
Time frame: 4 weeks
Body weight
Body weight assessed by bioelectrical impedance analysis (in kg)
Time frame: 4 weeks
Body composition
Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg)
Time frame: 4 weeks
Physical function - Isometric muscle strength
Hand grip strength assessed by hand dynamometer (in kg)
Time frame: 4 weeks
Physical function - Lower limb strength
30 second sit-to-stand test (number of sit-to-stand cycles)
Time frame: 4 weeks
Physical function - Endurance
Six-minute-walk test (walking distance in m)
Time frame: 4 weeks
Patient-reported performance status
ECOG performance status/Karnofsky index
Time frame: 4 weeks
subjective Physical activity
Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ)
Time frame: 4 weeks
objective Physical activity
Physical activity Level assessed by pedometer
Time frame: 4 weeks
Patient-reported Quality of Life (QoL)
EORTC QLQ - C30 questionnaire
Time frame: 4 weeks
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