Trial document





This trial has been registered retrospectively.
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  DRKS00016862

Trial Description

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Title

Nutritional Aspects in Head and Neck Cancer Patients undergoing Radio(chemo)therapy

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Trial Acronym

Head-Nut-Trial

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URL of the Trial

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Brief Summary in Lay Language

This study aims at examining the effects and the impact of the nutritional status on therapy outcome and therapy-related side effects in patients with head and neck cancer under radio(chemo)therapy.
We plan to include 70 patient with head and neck cancer who present at the Department of Radiotherapy and Radiooncology of the University Medical Center Hamburg-Eppendorf and/or its outpatient center to receive a curative treatment. All patients receive a pre- and posttherapeutic assessment of their nutritional status. Patients are randomized into an interventional and a control group. The latter does not receive nutritional counseling under ongoing radio(chemo)therapy, while patients of the interventional group will receive regular counseling by an ecotrophologist and a nutritional physician.
The main question is, whether patients of the interventional group benefit from the intensified nutritional counseling, thus presenting with less therapy-related side effects and improved outcome factors.

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Brief Summary in Scientific Language

Primary endpoints include the assessment of phase angle from bioelectric impedance measurements as an indicator for malnutrition. Also, we want to examine whether there is a difference in phase angle between our control and our interventional group.
Secondary endpoints include therapy-related toxicity, thus implying that patients undergoing an intensified dietary and nutritional counseling present with less therapy-related side effects (according to CTCAE-criteria). Also, assessment of quality of life in both groups (control and interventional group) and outcome factors including survival rates are to be examined.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00016862
  •   2019/03/11
  •   [---]*
  •   yes
  •   Approved
  •   PV5818, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   C00-C14 -  Malignant neoplasms of lip, oral cavity and pharynx
  •   R64 -  Cachexia
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Interventions/Observational Groups

  •   Interventional group - (intensified) nutritional counseling unter radio(chemo)therapy
  •   Control group - no nutritional counseling under ongoing radio(chemo)therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoints include the assessment of phase angle from bioelectric impedance measurements as an indicator for malnutrition. Also, we want to examine whether there is a difference in phase angle between our control and our interventional group.

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Secondary Outcome

Secondary endpoints include therapy-related toxicity, thus implying that patients undergoing an intensified dietary and nutritional counseling present with less therapy-related side effects (according to CTCAE-criteria). Also, assessment of quality of life in both groups (control and interventional group) and outcome factors including survival rates are to be examined.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/11/28
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

- Patients who undergo curative radio(chemo)therapy at the Department of Radiotherapy and Radiooncology of the University Medical Center Hamburg-Eppendorf (and/or its outpatient center) due to head and neck cancer
- Patients who are at least 18 years old

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Exclusion Criteria

- Pregnancy
- Patients who are not able sign written informed consent
- Patients with a cardiac defibrillator

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Addresses

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    • Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Hamburg-Eppendorf
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Klinik für Strahlentherapie und Radioonkologie des Universitätsklinikums Hamburg-Eppendorf / Ambulanzzentrum des UKE GmbH (Fachbereich: Strahlentherapie)
    • Ms.  Dr. med.  Anastassia  Löser 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    •   +49 (0)40-7410-53832
    •   +49 (0)40-7410-52846
    •   an.loeser at uke.de
    •   [---]*
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    • Klinik für Strahlentherapie und Radioonkologie des Universitätsklinikums Hamburg-Eppendorf / Ambulanzzentrum des UKE GmbH (Fachbereich: Strahlentherapie)
    • Ms.  Dr. med.  Anastassia  Löser 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    •   +49 (0)40-7410-53832
    •   +49 (0)40-7410-52846
    •   an.loeser at uke.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Klinik für Strahlentherapie und Radioonkologie des Universitätsklinikums Hamburg-Eppendorf / Ambulanzzentrum des UKE GmbH (Fachbereich: Strahlentherapie)
    • Ms. 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    •   [---]*
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    •   www.uke.de
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Status

  •   Recruiting ongoing
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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.