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

Primary Purpose

Hematological Malignancy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Taste-test
Standard care
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hematological Malignancy focused on measuring cancer, hematological, malignancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Hematology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention group

Standard dietary counseling

Arm Description

The patients will receive a individual dietary counseling based on the taste-test

The patients will receive a individual standard dietary counseling not based on the taste-test

Outcomes

Primary Outcome Measures

Consumption of energy as a percentage of estimated need
difference - before and after intervention

Secondary Outcome Measures

Fat-free-mass and fat-mass in percent (bioimpedance measurement)
difference - before and after intervention
Satisfaction (measured with EROTC QLQ-C30 version 3.0)
difference - before and after intervention. Higher scores means worse outcome. Lower scores means better outcomes.
Hand-grip-strength (measured with a dynamometer)
difference - before and after intervention
Body weight
difference - before and after intervention
Protein intake
difference - before and after intervention
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.

Full Information

First Posted
March 23, 2022
Last Updated
May 5, 2022
Sponsor
University of Copenhagen
Collaborators
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05364359
Brief Title
Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy
Acronym
HCP
Official Title
Individuel diætvejledning på Baggrund af Smagstest Hos Patienter Med hæmatologisk Cancer i Cytostatisk Behandling
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
July 28, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Copenhagen
Collaborators
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancy
Keywords
cancer, hematological, malignancy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
The patients will receive a individual dietary counseling based on the taste-test
Arm Title
Standard dietary counseling
Arm Type
Placebo Comparator
Arm Description
The patients will receive a individual standard dietary counseling not based on the taste-test
Intervention Type
Dietary Supplement
Intervention Name(s)
Taste-test
Other Intervention Name(s)
Dietary counseling
Intervention Description
Patients will receive a dietary counseling based on a simple taste-test
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Patients will receive a dietary counseling based on a standard dietary counseling for the patient group
Primary Outcome Measure Information:
Title
Consumption of energy as a percentage of estimated need
Description
difference - before and after intervention
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fat-free-mass and fat-mass in percent (bioimpedance measurement)
Description
difference - before and after intervention
Time Frame
6 weeks
Title
Satisfaction (measured with EROTC QLQ-C30 version 3.0)
Description
difference - before and after intervention. Higher scores means worse outcome. Lower scores means better outcomes.
Time Frame
6 weeks
Title
Hand-grip-strength (measured with a dynamometer)
Description
difference - before and after intervention
Time Frame
6 weeks
Title
Body weight
Description
difference - before and after intervention
Time Frame
6 weeks
Title
Protein intake
Description
difference - before and after intervention
Time Frame
6 weeks
Title
Burning/pain in the mouth (measured on a scale)
Description
difference - before and after intervention measured with Likert scale (1 to 5). Higher scores means a worse outcome. Lower scores means better outcomes.
Time Frame
6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Hematology
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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