Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy

Hematological Malignancy Clinical Trial

— HCP  

Official title:

Individuel diætvejledning på Baggrund af Smagstest Hos Patienter Med hæmatologisk Cancer i Cytostatisk Behandling

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05364359
• Other study ID #: HCP
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Neoplasms

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