Novel Form of Nutritional Supplementation in Cancer Patients

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Malnutrition; Cachexia; Cancer

Treatments: Dietary Supplement: sip feed; Dietary Supplement: gumdrops

Study type: Interventional

Funder types: Other

Identifiers

NCT03561610

ONOM

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Study group 1

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: sip feed

Study group 2

Experimental group

Description:

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

Treatment:

Dietary Supplement: gumdrops