CancerNCT03561610
Novel Form of Nutritional Supplementation in Cancer Patients
A study testing sip feed and gumdrops in people with Cancer and Malnutrition, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malnutrition, Cachexia
- What is being tested?
- sip feed and gumdrops
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with solid and hematological malignancies
- BMI < 20 kg/m² and/or NRS-2002 Score ≥ 3
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, 91052
Yurdaguel Zopf, Prof. Dr. med., +49 9131 85-45218, yurdaguel.zopf@uk-erlangen.de
Hans Joachim Herrmann, Dr. oec. troph., +49 9131 85-45017, hans.herrmann@uk-erlangen.de
About this study
Official title: Impact of a Novel Form of Oral Nutritional Supplement Application in Cancer Patients With a High Risk for Malnutrition
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.
- Conditions
- Cancer, Malnutrition, Cachexia
- Being tested
- sip feed, gumdrops
- Keywords
- cancer cachexia, malnutrition, nutritional supplement, sip feed, nutritional risk
- Medical subject headings
- Neoplasms, Malnutrition, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sip feedDietary supplement
normal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein)
gumdropsDietary supplement
normal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein)
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Active comparator | normal Nutrition + sip feed (covers individual energy and nutrient demands) Receives: Dietary Supplement: sip feed |
| Study group 2 | Experimental | normal Nutrition + gumdrops (covers individual energy and nutrient demands) Receives: Dietary Supplement: gumdrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Tolerance of the form of oral supplementation
assessment of hedonic and sensoric estimation of oral supplements by questionnaire
Measured: 4 weeks
Secondary outcomes (9)
Body weight
Body weight assessed by bioelectrical impedance analysis (in kg)
Measured: 4 weeks
Body composition
Skeletal muscle mass, Fat mass assessed by bioelectrical impedance analysis (in kg)
Measured: 4 weeks
Physical function - Isometric muscle strength
Hand grip strength assessed by hand dynamometer (in kg)
Measured: 4 weeks
Physical function - Lower limb strength
30 second sit-to-stand test (number of sit-to-stand cycles)
Measured: 4 weeks
Physical function - Endurance
Six-minute-walk test (walking distance in m)
Measured: 4 weeks
Patient-reported performance status
ECOG performance status/Karnofsky index
Measured: 4 weeks
subjective Physical activity
Physical activity Level assessed by International Physical Activity Questionnaire (IPAQ)
Measured: 4 weeks
objective Physical activity
Physical activity Level assessed by pedometer
Measured: 4 weeks
Patient-reported Quality of Life (QoL)
EORTC QLQ - C30 questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 May 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561610
- Sponsor's protocol ID
- ONOM
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Novel Form of Oral Nutritional Supplement Application in Cancer Patients With a High Risk for Malnutrition
- ClinicalTrials.gov ID
- NCT03561610
- Acronym / sponsor ID
- ONOM
- Conditions
- Cancer, Malnutrition, Cachexia
- Keywords
- cancer cachexia, malnutrition, nutritional supplement, sip feed, nutritional risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | Active comparator | Dietary Supplement: sip feednormal Nutrition + sip feed (covers individual energy and nutrient demands) |
| Study group 2 | Experimental | Dietary Supplement: gumdropsnormal Nutrition + gumdrops (covers individual energy and nutrient demands) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients with solid and hematological malignancies
- BMI < 20 kg/m² and/or NRS-2002 Score ≥ 3
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sip feednormal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein) | Dietary supplement | Study group 1 |
| gumdropsnormal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein) | Dietary supplement | Study group 2 |
Primary outcome
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
Tolerance of the form of oral supplementation
Time frame: 4 weeks
assessment of hedonic and sensoric estimation of oral supplements by questionnaire
9 secondary outcomes
Body weight
Time frame: 4 weeks
Body composition
Time frame: 4 weeks
Physical function - Isometric muscle strength
Time frame: 4 weeks
Physical function - Lower limb strength
Time frame: 4 weeks
Physical function - Endurance
Time frame: 4 weeks
Patient-reported performance status
Time frame: 4 weeks
subjective Physical activity
Time frame: 4 weeks
objective Physical activity
Time frame: 4 weeks
Patient-reported Quality of Life (QoL)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sip feed and gumdrops in people with Cancer and Malnutrition, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.