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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05364359
Other study ID # HCP
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 28, 2022
Est. completion date August 15, 2022

Study information

Verified date May 2022
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date August 15, 2022
Est. primary completion date July 28, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Pacemaker

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Taste-test
Patients will receive a dietary counseling based on a simple taste-test
Other:
Standard care
Patients will receive a dietary counseling based on a standard dietary counseling for the patient group

Locations

Country Name City State
Denmark Department of Hematology Roskilde

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Consumption of energy as a percentage of estimated need difference - before and after intervention 6 weeks
Secondary Fat-free-mass and fat-mass in percent (bioimpedance measurement) difference - before and after intervention 6 weeks
Secondary Satisfaction (measured with EROTC QLQ-C30 version 3.0) difference - before and after intervention. Higher scores means worse outcome. Lower scores means better outcomes. 6 weeks
Secondary Hand-grip-strength (measured with a dynamometer) difference - before and after intervention 6 weeks
Secondary Body weight difference - before and after intervention 6 weeks
Secondary Protein intake difference - before and after intervention 6 weeks
Secondary 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. 6 weeks
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