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

May 5, 2022 updated by: University of Copenhagen

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Department of Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
The patients will receive a individual dietary counseling based on the taste-test
Dietary supplement: Taste-test
Patients will receive a dietary counseling based on a simple taste-test
Other Names:
  • Dietary counseling
Placebo Comparator: Standard dietary counseling
The patients will receive a individual standard dietary counseling not based on the taste-test
Other: Standard care
Patients will receive a dietary counseling based on a standard dietary counseling for the patient group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of energy as a percentage of estimated need
Time Frame: 6 weeks
difference - before and after intervention
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat-free-mass and fat-mass in percent (bioimpedance measurement)
Time Frame: 6 weeks
difference - before and after intervention
6 weeks
Satisfaction (measured with EROTC QLQ-C30 version 3.0)
Time Frame: 6 weeks
difference - before and after intervention. Higher scores means worse outcome. Lower scores means better outcomes.
6 weeks
Hand-grip-strength (measured with a dynamometer)
Time Frame: 6 weeks
difference - before and after intervention
6 weeks
Body weight
Time Frame: 6 weeks
difference - before and after intervention
6 weeks
Protein intake
Time Frame: 6 weeks
difference - before and after intervention
6 weeks
Burning/pain in the mouth (measured on a scale)
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Anticipated)

July 28, 2022

Study Completion (Anticipated)

August 15, 2022

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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