Novel Form of Nutritional Supplementation in Cancer Patients

Not Applicable

• Conditions: Cancer; Cachexia; Malnutrition
• Interventions: Dietary Supplement: gumdrops; Dietary Supplement: sip feed

• Registration Number: NCT03561610
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Status Verified: 2018-06
• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Study First Posted: 2018-06-19
• Last Update Posted: 2018-06-19
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study group 2	gumdrops	normal Nutrition + gumdrops (covers individual energy and nutrient demands)
Study group 1	sip feed	normal Nutrition + sip feed (covers individual energy and nutrient demands)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Body weight	4 weeks	Body weight assessed by bioelectrical impedance analysis (in kg)
Body composition	4 weeks	Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg)
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)
Patient-reported performance status	4 weeks	ECOG performance status/Karnofsky index
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

Trial Locations

Locations (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany