Trial document




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  DRKS00020361

Trial Description

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Title

TASTE II Trial - Impact of taste and smell training and structured, individualized nutritional intervention to improve taste perception in patients receiving chemotherapy - a multicenter trial

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Trial Acronym

TASTE II

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Two-thirds of cancer patients report taste disorders during and after chemotherapy. Taste disorders impact on nutritional status which is highly relevant for treatment efficacy and overall prognosis. Improvement of taste disorder is of particular importance for cancer patients’ outcomes, thus the TASTE trial was conducted to improve taste disorders with a taste and smell training.
The present TASTE II trial analyzes the effectiveness of nutritional counseling, taste and smell training, and the use of tooth oil to improve taste perception in patients undergoing chemotherapy. This study is to prove the results of the TASTE I study in a controlled and randomized design in four locations in Germany.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00020361
  •   2020/10/28
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  •   yes
  •   Approved
  •   PV5471, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   R43.2 -  Parageusia
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Interventions/Observational Groups

  •   Intervention group (patients with taste disorder (<9 points))

    - Individual nutritional counseling (30-45 minutes)
    - Smell and taste training (30 minutes)
    - Provision of odor sticks, tooth oil and information on taste training
  •   Control group (patients with taste disorder (<9 points))

    - general nutrition information, no advice or further interventions
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is the improvement of the objective taste perception by 2 Taste strip points at week 12 in at least 50% of the patients from the intervention group compared to the control group.

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Secondary Outcome

- Improvement of the objective taste perception by 2 points at week 52 in at least 50% of the patients in the intervention group compared to the control group
- Improvement of the objective recognition of "salty", "sweet", "sour" and "bitter" (measured with taste strips "Taste Strips") compared to the control group
- Improvement of the subjective taste perception (measured by means of the anamnesis questionnaire according to Prof. Hummel) compared to the control group
- Recording of nutritional status (measured using PG-SGA Short Form)
- Assessment of the malnutrition risk (measured using the Malnutrition Universal Screening Tool (MUST))
- Feasibility and acceptance of taste and smell training
- Recording of body composition (muscle and fat mass, phase angle) (measured using bioimpedance analysis (BIA) measurement) (center-specific)
- Recording of biochemical parameters: zinc, selenium, CrP (C-reactive protein), glucose, albumin
- Recording of the quality of life as well as disease and therapy-related symptoms of all study patients (measured by EORTC-C30, FATIQUE questionnaire, polyneuropathy questionnaire)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/11/02
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients with an objective taste disorder (measured using taste strips "Taste Strips") with a point score <9 points
- Patients with active cancer receiving outpatient chemotherapy including taxanes, platinum derivatives, athracyclines and / or antimetabolites
- Age <18 years
- existing written declaration of consent

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Exclusion Criteria

- Presence of a genetic metabolic disorder
- Treatment / previous treatment for an eating disorder (anorexia, bulimia, binge eating)
- Parenteral nutrition, enteral supplementary food (food via PEG or PEJ) or with high-calorie drinking food (if> 50% of the energy requirement is covered by drinking food) under therapy for tumor cachexia
- Radiation in the head and neck area
- pregnancy

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Addresses

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    • Hubertus Wald Tumorzentrum - Universitäres Cancer Center HamburgUniversitäres Klinikum Hamburg- Eppendorf (UKE)
    • Ms.  Julia  von Grundherr 
    • Martinistraße
    • 20246  Hamburg
    • Germany
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    • Hubertus Wald Tumorzentrum - Universitäres Cancer Center HamburgUniversitäres Klinikum Hamburg- Eppendorf (UKE)
    • Ms.  B.Sc.  Julia  von Grundherr 
    • Martinistraße
    • 20246  Hamburg
    • Germany
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    • Hubertus Wald Tumorzentrum - Universitäres Cancer Center HamburgUniversitäres Klinikum Hamburg- Eppendorf (UKE)
    • Ms.  Julia  von Grundherr 
    • Martinistraße
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Hamburger Krebsgesellschaft e.V.Geschäftsstelle und Krebsberatungsdienst
    • Butenfeld 18
    • 22529  Hamburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.