Novel Form of Nutritional Supplementation in Cancer Patients

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03561610
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Malnutrition; Cachexia	Dietary Supplement: sip feed; Dietary Supplement: gumdrops	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of a Novel Form of Oral Nutritional Supplement Application in Cancer Patients With a High Risk for Malnutrition
• Actual Study Start Date: May 1, 2018
• Anticipated Primary Completion Date: May 1, 2019
• Anticipated Study Completion Date: May 1, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Compliance [4 weeks]

   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

2. Tolerance of the form of oral supplementation [4 weeks]

   assessment of hedonic and sensoric estimation of oral supplements by questionnaire

Secondary Outcome Measures

1. Body weight [4 weeks]

   Body weight assessed by bioelectrical impedance analysis (in kg)

2. Body composition [4 weeks]

   Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg)

3. Physical function - Isometric muscle strength [4 weeks]

   Hand grip strength assessed by hand dynamometer (in kg)

4. Physical function - Lower limb strength [4 weeks]

   30 second sit-to-stand test (number of sit-to-stand cycles)

5. Physical function - Endurance [4 weeks]

   Six-minute-walk test (walking distance in m)

6. Patient-reported performance status [4 weeks]

   ECOG performance status/Karnofsky index

7. subjective Physical activity [4 weeks]

   Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ)

8. objective Physical activity [4 weeks]

   Physical activity Level assessed by pedometer

9. Patient-reported Quality of Life (QoL) [4 weeks]

   EORTC QLQ - C30 questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg	Erlangen		Germany	91052

Sponsors and Collaborators

• University of Erlangen-Nürnberg Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT03561610
• Other Study ID Numbers: ONOM
• First Posted: Jun 19, 2018
• Last Update Posted: Jun 19, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Erlangen-Nürnberg Medical School: cancer cachexia; malnutrition; nutritional supplement; sip feed; nutritional risk
• Additional relevant MeSH terms: Malnutrition; Wasting Syndrome; Cachexia

Study Results

No Results Posted as of Jun 19, 2018