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

Sponsor
University of Copenhagen (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05364359
Collaborator
Zealand University Hospital (Other)
40
Enrollment
1
Location
2
Arms
4.6
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Taste-test
  • Other: Standard care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Individuel diætvejledning på Baggrund af Smagstest Hos Patienter Med hæmatologisk Cancer i Cytostatisk Behandling
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Jul 28, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Consumption of energy as a percentage of estimated need [6 weeks]

      difference - before and after intervention

    Secondary Outcome Measures

    1. Fat-free-mass and fat-mass in percent (bioimpedance measurement) [6 weeks]

      difference - before and after intervention

    2. Satisfaction (measured with EROTC QLQ-C30 version 3.0) [6 weeks]

      difference - before and after intervention. Higher scores means worse outcome. Lower scores means better outcomes.

    3. Hand-grip-strength (measured with a dynamometer) [6 weeks]

      difference - before and after intervention

    4. Body weight [6 weeks]

      difference - before and after intervention

    5. Protein intake [6 weeks]

      difference - before and after intervention

    6. Burning/pain in the mouth (measured on a scale) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Hematology Roskilde Denmark 4000

    Sponsors and Collaborators

    • University of Copenhagen
    • Zealand University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Copenhagen
    ClinicalTrials.gov Identifier:
    NCT05364359
    Other Study ID Numbers:
    • HCP
    First Posted:
    May 6, 2022
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Copenhagen
    cancer
    hematological
    malignancy
    Additional relevant MeSH terms:
    Neoplasms
    Hematologic Neoplasms

    Study Results

    No Results Posted as of May 6, 2022