Novel Form of Nutritional Supplementation in Cancer Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03561610
• Other study ID #: ONOM
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: June 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Cancer
• Malnutrition

Intervention

Dietary Supplement:
• sip feed
normal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein)
• gumdrops
normal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein)

Locations

Country	Name	City	State
Germany	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Tolerance of the form of oral supplementation	assessment of hedonic and sensoric estimation of oral supplements by questionnaire	4 weeks
Secondary	Body weight	Body weight assessed by bioelectrical impedance analysis (in kg)	4 weeks
Secondary	Body composition	Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg)	4 weeks
Secondary	Physical function - Isometric muscle strength	Hand grip strength assessed by hand dynamometer (in kg)	4 weeks
Secondary	Physical function - Lower limb strength	30 second sit-to-stand test (number of sit-to-stand cycles)	4 weeks
Secondary	Physical function - Endurance	Six-minute-walk test (walking distance in m)	4 weeks
Secondary	Patient-reported performance status	ECOG performance status/Karnofsky index	4 weeks
Secondary	subjective Physical activity	Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ)	4 weeks
Secondary	objective Physical activity	Physical activity Level assessed by pedometer	4 weeks
Secondary	Patient-reported Quality of Life (QoL)	EORTC QLQ - C30 questionnaire	4 weeks