Novel Form of Nutritional Supplementation in Cancer Patients

NCT03561610 | Unknown

• 1 other identifier: ONOM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Malnutrition; Cachexia

Keywords

cancer cachexia; malnutrition; nutritional supplement; sip feed; nutritional risk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Body weight

  4 weeks

• Body composition

  4 weeks

• Physical function - Isometric muscle strength

  4 weeks

• Physical function - Lower limb strength

  4 weeks

• Physical function - Endurance

  4 weeks

Study Arms (2)

Study group 1

ACTIVE COMPARATOR

normal Nutrition + sip feed (covers individual energy and nutrient demands)

Dietary Supplement: sip feed

Study group 2

EXPERIMENTAL

normal Nutrition + gumdrops (covers individual energy and nutrient demands)

Dietary Supplement: gumdrops

Interventions

sip feed DIETARY_SUPPLEMENT

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

Study group 1

gumdrops DIETARY_SUPPLEMENT

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

Study group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients with solid and hematological malignancies
• BMI \< 20 kg/m² and/or NRS-2002 Score ≥ 3

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, 91052, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms; Malnutrition; Cachexia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 19, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)