Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy
HCP
Individuel diætvejledning på Baggrund af Smagstest Hos Patienter Med hæmatologisk Cancer i Cytostatisk Behandling
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2022
CompletedStudy Start
First participant enrolled
March 28, 2022
CompletedFirst Posted
Study publicly available on registry
May 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2022
CompletedMay 6, 2022
May 1, 2022
4 months
March 23, 2022
May 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Consumption of energy as a percentage of estimated need
difference - before and after intervention
6 weeks
Secondary Outcomes (6)
Fat-free-mass and fat-mass in percent (bioimpedance measurement)
6 weeks
Satisfaction (measured with EROTC QLQ-C30 version 3.0)
6 weeks
Hand-grip-strength (measured with a dynamometer)
6 weeks
Body weight
6 weeks
Protein intake
6 weeks
- +1 more secondary outcomes
Study Arms (2)
Intervention group
ACTIVE COMPARATORThe patients will receive a individual dietary counseling based on the taste-test
Standard dietary counseling
PLACEBO COMPARATORThe patients will receive a individual standard dietary counseling not based on the taste-test
Interventions
Patients will receive a dietary counseling based on a simple taste-test
Patients will receive a dietary counseling based on a standard dietary counseling for the patient group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Zealand University Hospitalcollaborator
Study Sites (1)
Department of Hematology
Roskilde, 4000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2022
First Posted
May 6, 2022
Study Start
March 28, 2022
Primary Completion
July 28, 2022
Study Completion
August 15, 2022
Last Updated
May 6, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share