Novel Form of Nutritional Supplementation in Cancer Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Malnutrition; Cachexia
• Intervention / Treatment: Dietary supplement: sip feed; Dietary supplement: gumdrops

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91052
    • Recruiting
    • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: malnutrition; cancer cachexia; nutritional supplement; nutritional risk; sip feed
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Malnutrition; Wasting Syndrome; Cachexia
• Other Study ID Numbers: ONOM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No