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Novel Form of Nutritional Supplementation in Cancer Patients

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ClinicalTrials.gov Identifier: NCT03561610
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Compliance [ Time Frame: 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 [ Time Frame: 4 weeks ]
    assessment of hedonic and sensoric estimation of oral supplements by questionnaire


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 4 weeks ]
    Body weight assessed by bioelectrical impedance analysis (in kg)

  2. Body composition [ Time Frame: 4 weeks ]
    Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg)

  3. Physical function - Isometric muscle strength [ Time Frame: 4 weeks ]
    Hand grip strength assessed by hand dynamometer (in kg)

  4. Physical function - Lower limb strength [ Time Frame: 4 weeks ]
    30 second sit-to-stand test (number of sit-to-stand cycles)

  5. Physical function - Endurance [ Time Frame: 4 weeks ]
    Six-minute-walk test (walking distance in m)

  6. Patient-reported performance status [ Time Frame: 4 weeks ]
    ECOG performance status/Karnofsky index

  7. subjective Physical activity [ Time Frame: 4 weeks ]
    Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ)

  8. objective Physical activity [ Time Frame: 4 weeks ]
    Physical activity Level assessed by pedometer

  9. Patient-reported Quality of Life (QoL) [ Time Frame: 4 weeks ]
    EORTC QLQ - C30 questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561610


Locations
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Germany
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91052
Contact: Yurdaguel Zopf, Prof. Dr. med.    +49 9131 85-45218    yurdaguel.zopf@uk-erlangen.de   
Contact: Hans Joachim Herrmann, Dr. oec. troph.    +49 9131 85-45017    hans.herrmann@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03561610     History of Changes
Other Study ID Numbers: ONOM
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Malnutrition
Wasting Syndrome
Cachexia
Nutrition Disorders
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrients
Growth Substances
Physiological Effects of Drugs