Novel Form of Nutritional Supplementation in Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Novel Form of Oral Nutritional Supplement Application in Cancer Patients With a High Risk for Malnutrition

Conditions
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Cancer, Malnutrition, Cachexia

Intervention / Treatment
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* Dietary Supplement: sip feed
* Dietary Supplement: gumdrops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group 1<br>normal Nutrition + sip feed (covers individual energy and nutrient demands) | Dietary Supplement: sip feed<br>* normal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein)<br>|
| Experimental: Study group 2<br>normal Nutrition + gumdrops (covers individual energy and nutrient demands) | Dietary Supplement: gumdrops<br>* normal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer cachexia, malnutrition, nutritional supplement, sip feed, nutritional risk