Hematological MalignancyHCPNCT05364359
Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy
A study testing Taste-test in people with Hematological Malignancy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate whether a simple taste-test will increase the intake of energy as part of the individual dietary counseling. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematological Malignancy
- What is being tested?
- Taste-test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Mar 2022to 15 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18 years or older
- Able to understand the "Participant Information" paper
- Diagnosed with hematological cancer
- Must be undergoing chemotherapy (at least one treatment during the study)
- Outpatient
- Be able to take pictures of meals (and send to the sub-investigators)
- Be able to speak and read the danish language
Who cannot join
- Pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individuel diætvejledning på Baggrund af Smagstest Hos Patienter Med hæmatologisk Cancer i Cytostatisk Behandling
The purpose of the study is to investigate whether a simple taste-test will increase the intake of energy as part of the individual dietary counseling.
Read the detailed description
The investigators will investigate the tastes (umami, bitter, salty, sweet and sour) that the patients prefers in order to increase the energy intake and reduce the risk of weight loss and loss of fat-free mass for patients with hematological cancer.
The study will be conducted as a single blinded randomized controlled trial. 40 patients will be recruited, and will be divided into two groups; the intervention group and the control group. The patients will not know which group they belong to.
- Conditions
- Hematological Malignancy
- Being tested
- Taste-test, Standard care
- Keywords
- cancer, hematological, malignancy
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taste-testDietary supplement
Also called Dietary counseling
Patients will receive a dietary counseling based on a simple taste-test
Standard careOther
Patients will receive a dietary counseling based on a standard dietary counseling for the patient group
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The patients will receive a individual dietary counseling based on the taste-test Receives: Dietary Supplement: Taste-test |
| Standard dietary counseling | Placebo comparator | The patients will receive a individual standard dietary counseling not based on the taste-test Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of energy as a percentage of estimated need
difference - before and after intervention
Measured: 6 weeks
Secondary outcomes (6)
Fat-free-mass and fat-mass in percent (bioimpedance measurement)
difference - before and after intervention
Measured: 6 weeks
Satisfaction (measured with EROTC QLQ-C30 version 3.0)
difference - before and after intervention. Higher scores means worse outcome. Lower scores means better outcomes.
Measured: 6 weeks
Hand-grip-strength (measured with a dynamometer)
difference - before and after intervention
Measured: 6 weeks
Body weight
difference - before and after intervention
Measured: 6 weeks
Protein intake
difference - before and after intervention
Measured: 6 weeks
Burning/pain in the mouth (measured on a scale)
difference - before and after intervention measured with Likert scale (1 to 5). Higher scores means a worse outcome. Lower scores means better outcomes.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start28 Mar 2022
- Primary completion28 Jul 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364359
- Sponsor's protocol ID
- HCP
- Acronym
- HCP
- Status last verified
- May 2022
- First submitted
- 23 Mar 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individuel diætvejledning på Baggrund af Smagstest Hos Patienter Med hæmatologisk Cancer i Cytostatisk Behandling
- ClinicalTrials.gov ID
- NCT05364359
- Acronym / sponsor ID
- HCP / HCP
- Conditions
- Hematological Malignancy
- Keywords
- cancer, hematological, malignancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Zealand University Hospital
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 28 Jul 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 6 May 2022 (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.
The purpose of the study is to investigate whether a simple taste-test will increase the intake of energy as part of the individual dietary counseling.
Detailed description
The investigators will investigate the tastes (umami, bitter, salty, sweet and sour) that the patients prefers in order to increase the energy intake and reduce the risk of weight loss and loss of fat-free mass for patients with hematological cancer.
The study will be conducted as a single blinded randomized controlled trial. 40 patients will be recruited, and will be divided into two groups; the intervention group and the control group. The patients will not know which group they belong to.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: Taste-testThe patients will receive a individual dietary counseling based on the taste-test |
| Standard dietary counseling | Placebo comparator | Other: Standard careThe patients will receive a individual standard dietary counseling not based on the taste-test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Able to understand the "Participant Information" paper
- Diagnosed with hematological cancer
- Must be undergoing chemotherapy (at least one treatment during the study)
- Outpatient
Key exclusion criteria (1 listed)
- Pacemaker
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 |
|---|---|---|
| Taste-testAlso: Dietary counselingPatients will receive a dietary counseling based on a simple taste-test | Dietary supplement | Intervention group |
| Standard carePatients will receive a dietary counseling based on a standard dietary counseling for the patient group | Other | Standard dietary counseling |
Primary outcome
Consumption of energy as a percentage of estimated need
Time frame: 6 weeks
difference - before and after intervention
6 secondary outcomes
Fat-free-mass and fat-mass in percent (bioimpedance measurement)
Time frame: 6 weeks
Satisfaction (measured with EROTC QLQ-C30 version 3.0)
Time frame: 6 weeks
Hand-grip-strength (measured with a dynamometer)
Time frame: 6 weeks
Body weight
Time frame: 6 weeks
Protein intake
Time frame: 6 weeks
Burning/pain in the mouth (measured on a scale)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taste-test in people with Hematological Malignancy, run by University of Copenhagen 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 7 inclusion and 1 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 6 May 2022. 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. Some participants in this study may receive a placebo. 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?
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?
Consumption of energy as a percentage of estimated need (time frame: 6 weeks). 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 6 May 2022.