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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group 1 | Active Comparator | normal Nutrition + sip feed (covers individual energy and nutrient demands) |
|
| Study group 2 | Experimental | normal Nutrition + gumdrops (covers individual energy and nutrient demands) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sip feed | Dietary Supplement | normal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | 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 | 4 weeks |
| Tolerance of the form of oral supplementation | assessment of hedonic and sensoric estimation of oral supplements by questionnaire | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight assessed by bioelectrical impedance analysis (in kg) | 4 weeks |
| Body composition | Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg | Recruiting | Erlangen | 91052 | Germany |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D044342 | Malnutrition |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
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| gumdrops | Dietary Supplement | normal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein) |
|
| 4 weeks |
| Physical function - Isometric muscle strength | Hand grip strength assessed by hand dynamometer (in kg) | 4 weeks |
| Physical function - Lower limb strength | 30 second sit-to-stand test (number of sit-to-stand cycles) | 4 weeks |
| Physical function - Endurance | Six-minute-walk test (walking distance in m) | 4 weeks |
| Patient-reported performance status | ECOG performance status/Karnofsky index | 4 weeks |
| subjective Physical activity | Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ) | 4 weeks |
| objective Physical activity | Physical activity Level assessed by pedometer | 4 weeks |
| Patient-reported Quality of Life (QoL) | EORTC QLQ - C30 questionnaire | 4 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |