Cachexia, Cancer, Malnutrition
Conditions
Keywords
cancer cachexia, malnutrition, nutritional supplement, sip feed, nutritional risk
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTsip feed
normal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein)
DIETARY_SUPPLEMENTgumdrops
normal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein)
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients with solid and hematological malignancies * BMI \< 20 kg/m² and/or NRS-2002 Score ≥ 3
Exclusion criteria
* pregnant or nursing women * persons with psychiatric disorders with doubts about legal and cognitive capacity * participation in nutritional Intervention Trials within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | 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 |
| Tolerance of the form of oral supplementation | 4 weeks | assessment of hedonic and sensoric estimation of oral supplements by questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical function - Isometric muscle strength | 4 weeks | Hand grip strength assessed by hand dynamometer (in kg) |
| Physical function - Lower limb strength | 4 weeks | 30 second sit-to-stand test (number of sit-to-stand cycles) |
| Physical function - Endurance | 4 weeks | Six-minute-walk test (walking distance in m) |
| Body weight | 4 weeks | Body weight assessed by bioelectrical impedance analysis (in kg) |
| subjective Physical activity | 4 weeks | Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ) |
| objective Physical activity | 4 weeks | Physical activity Level assessed by pedometer |
| Patient-reported Quality of Life (QoL) | 4 weeks | EORTC QLQ - C30 questionnaire |
| Patient-reported performance status | 4 weeks | ECOG performance status/Karnofsky index |
| Body composition | 4 weeks | Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg) |
Countries
Germany
Outcome results
None listed