Novel Form of Nutritional Supplementation in Cancer Patients

NCT ID: NCT03561610

Last Updated: 2018-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Malnutrition Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Study group 1

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

Group Type ACTIVE_COMPARATOR

sip feed

Intervention Type DIETARY_SUPPLEMENT

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

Study group 2

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

Group Type EXPERIMENTAL

gumdrops

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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sip feed

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

Intervention Type DIETARY_SUPPLEMENT

gumdrops

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Yurdaguel Zopf, Prof. Dr. med.

Role: primary

+49 9131 85-45218

Hans Joachim Herrmann, Dr. oec. troph.

Role: backup

+49 9131 85-45017

Other Identifiers

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ONOM

Identifier Type: -

Identifier Source: org_study_id

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