Novel Form of Nutritional Supplementation in Cancer Patients

NCT03561610 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-06-19

No results posted yet for this study

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.

Conditions

  • Cancer
  • Malnutrition
  • Cachexia

Interventions

DIETARY_SUPPLEMENT

sip feed

normal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein)

DIETARY_SUPPLEMENT

gumdrops

normal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein)

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-05-01
Completion
2019-05-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03561610 on ClinicalTrials.gov