Hematological DiseaseNCT02447237
Randomized Trial:the Effect of Liquid Food on the Intake of Energy and Protein in Malignant Hematologic Patients
A study testing dietary counselling in people with Hematological Disease and Delayed Gastric Emptying, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial summary
The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Disease, Delayed Gastric Emptying, Malignant Disease
- What is being tested?
- dietary counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Jul 2015
- 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
- patients with leukemia, lymphoma or other malignant hematological disease
- adults
- be able to talk and understand danish
- be able to eat both solid and liquid food
Who cannot join
- not able to cooperate
- need for total tube or parenteral nutrition
- need for dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial About the Effect of Liquid Compared to Solid Food on the Intake of Energy and Protein in Patients With Leukemia, Lymphoma or Other Malignant Hematologic Disease
The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food.
Read the detailed description
The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food. Both groups need to register their dietary intake in a period of 14 days and will be weighed three times during the intervention. At the end of the intervention they need to fill out a questionnaire.
- Being tested
- dietary counselling
- Keywords
- liquid diet, solid diet
- Medical subject headings
- Hematologic Diseases, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary counsellingOther
the participants will receive dietary counselling in fulfilling their need of energy and protein according to the group they are randomized to (either solid or liquid food).
| Study group | Role | What they receive |
|---|---|---|
| liquid food | Experimental | dietary counselling in fulfilling need of protein and energy through liquid food Receives: Other: dietary counselling |
| solid food | Other | dietary counselling in fulfilling need of protein and energy through solid food Receives: Other: dietary counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake of energy and protein
assessed by dietary records from both groups
Measured: 14 days
Secondary outcomes (7)
Weightloss change in percent from baseline
calculated by comparing baseline weight with the weight after 14 days
Measured: 14 days
Amount of infections
infection, e.g. fever, diarrhoea will be assessed from the medical record
Measured: 14 days
Need for tube feeding and parenteral nutrition
will be assessed from the medical record
Measured: 14 days
patient satisfaction as well as perception of own nutritional status
will be assessed from a questionnaire filled out by the patient after completing the intervention
Measured: 14 days
patients compliance of following the nutritional guidelines in the liquid group
calculating the amount of energy from liquid food compared to the total energy intake using the dietary records
Measured: 14 days
Dose of cytostatics
will be assessed from the medical records
Measured: 14 days
unplanned hospital stay
will be assessed from the medical record
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R Andersen, Lektor, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447237
- Sponsor's protocol ID
- H-4-2014-113
- Status last verified
- Aug 2016
- First submitted
- 25 Mar 2015
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial About the Effect of Liquid Compared to Solid Food on the Intake of Energy and Protein in Patients With Leukemia, Lymphoma or Other Malignant Hematologic Disease
- ClinicalTrials.gov ID
- NCT02447237
- Acronym / sponsor ID
- H-4-2014-113
- Keywords
- liquid diet, solid diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 May 2015 (estimated)
- 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.
The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food.
Detailed description
The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food. Both groups need to register their dietary intake in a period of 14 days and will be weighed three times during the intervention. At the end of the intervention they need to fill out a questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liquid food | Experimental | Other: dietary counsellingdietary counselling in fulfilling need of protein and energy through liquid food |
| solid food | Other | Other: dietary counsellingdietary counselling in fulfilling need of protein and energy through solid food |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with leukemia, lymphoma or other malignant hematological disease
- adults
- be able to talk and understand danish
- be able to eat both solid and liquid food
Key exclusion criteria (3 listed)
- not able to cooperate
- need for total tube or parenteral nutrition
- need for dialysis
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 |
|---|---|---|
| dietary counsellingthe participants will receive dietary counselling in fulfilling their need of energy and protein according to the group they are randomized to (either solid or liquid food). | Other | liquid food, solid food |
Primary outcome
Intake of energy and protein
Time frame: 14 days
assessed by dietary records from both groups
7 secondary outcomes
Weightloss change in percent from baseline
Time frame: 14 days
Amount of infections
Time frame: 14 days
Need for tube feeding and parenteral nutrition
Time frame: 14 days
patient satisfaction as well as perception of own nutritional status
Time frame: 14 days
patients compliance of following the nutritional guidelines in the liquid group
Time frame: 14 days
Dose of cytostatics
Time frame: 14 days
unplanned hospital stay
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Hematological Disease
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
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.
Jens R Andersen, Lektor study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary counselling in people with Hematological Disease and Delayed Gastric Emptying, run by Jens Rikardt Andersen at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 26 Aug 2016. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intake of energy and protein (time frame: 14 days). 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 26 Aug 2016.