Back to resultsNovel Form of Nutritional Supplementation in Cancer Patients
Primary Purpose
Cancer, Malnutrition, Cachexia
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sip feed
gumdrops
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring cancer cachexia, malnutrition, nutritional supplement, sip feed, nutritional risk
Eligibility 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
Sites / Locations
- Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-NurembergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Study group 1
Study group 2
Arm Description
normal Nutrition + sip feed (covers individual energy and nutrient demands)
normal Nutrition + gumdrops (covers individual energy and nutrient demands)
Outcomes
Primary Outcome Measures
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
Tolerance of the form of oral supplementation
assessment of hedonic and sensoric estimation of oral supplements by questionnaire
Secondary Outcome Measures
Body weight
Body weight assessed by bioelectrical impedance analysis (in kg)
Body composition
Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg)
Physical function - Isometric muscle strength
Hand grip strength assessed by hand dynamometer (in kg)
Physical function - Lower limb strength
30 second sit-to-stand test (number of sit-to-stand cycles)
Physical function - Endurance
Six-minute-walk test (walking distance in m)
Patient-reported performance status
ECOG performance status/Karnofsky index
subjective Physical activity
Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ)
objective Physical activity
Physical activity Level assessed by pedometer
Patient-reported Quality of Life (QoL)
EORTC QLQ - C30 questionnaire
Full Information
NCT ID
NCT03561610
First Posted
June 4, 2018
Last Updated
June 18, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03561610
Brief Title
Novel Form of Nutritional Supplementation in Cancer Patients
Official Title
Impact of a Novel Form of Oral Nutritional Supplement Application in Cancer Patients With a High Risk for Malnutrition
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Malnutrition, Cachexia
Keywords
cancer cachexia, malnutrition, nutritional supplement, sip feed, nutritional risk
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group 1
Arm Type
Active Comparator
Arm Description
normal Nutrition + sip feed (covers individual energy and nutrient demands)
Arm Title
Study group 2
Arm Type
Experimental
Arm Description
normal Nutrition + gumdrops (covers individual energy and nutrient demands)
Intervention Type
Dietary Supplement
Intervention Name(s)
sip feed
Intervention Description
normal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein)
Intervention Type
Dietary Supplement
Intervention Name(s)
gumdrops
Intervention Description
normal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein)
Primary Outcome Measure Information:
Title
Compliance
Description
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
Time Frame
4 weeks
Title
Tolerance of the form of oral supplementation
Description
assessment of hedonic and sensoric estimation of oral supplements by questionnaire
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Body weight
Description
Body weight assessed by bioelectrical impedance analysis (in kg)
Time Frame
4 weeks
Title
Body composition
Description
Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg)
Time Frame
4 weeks
Title
Physical function - Isometric muscle strength
Description
Hand grip strength assessed by hand dynamometer (in kg)
Time Frame
4 weeks
Title
Physical function - Lower limb strength
Description
30 second sit-to-stand test (number of sit-to-stand cycles)
Time Frame
4 weeks
Title
Physical function - Endurance
Description
Six-minute-walk test (walking distance in m)
Time Frame
4 weeks
Title
Patient-reported performance status
Description
ECOG performance status/Karnofsky index
Time Frame
4 weeks
Title
subjective Physical activity
Description
Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ)
Time Frame
4 weeks
Title
objective Physical activity
Description
Physical activity Level assessed by pedometer
Time Frame
4 weeks
Title
Patient-reported Quality of Life (QoL)
Description
EORTC QLQ - C30 questionnaire
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof. Dr. med.
Phone
+49 9131 85-45218
Email
yurdaguel.zopf@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Hans Joachim Herrmann, Dr. oec. troph.
Phone
+49 9131 85-45017
Email
hans.herrmann@uk-erlangen.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Novel Form of Nutritional Supplementation in Cancer Patients
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