Trial document




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  DRKS00003361

Trial Description

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Title

Changes in the sense of smell and taste in patients undergoing chemotherapy for head and neck malignancies

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Trial Acronym

chemical senses during chemotherapy

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with malignant diseases undergoing a chemotherapy suffer from different aspects of quality of life loss. A proper sense of smell and taste is crucial for a good quality of life and an important fact in nutrition. Until now very few studies investigate the influence of cheomtherapy on these chemical sneses with validated tests. This aspect should be examined in patients during chemotherpay for head and neck malignancies on different points of time.

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Brief Summary in Scientific Language

In patients receiving chemotherapy with Cisplatine, 5-Fu and Taxotere for head & neck squamous cell carcinomas, the olfactory TDI-Score (threshold, discrimination and identification) is determined by the Sniffin´ Sticks test before the start of the cyclus and directly afterwards. Additionally the sense of taste is evaluated by the whole mouth test at the same date. The maximum number of cycles is 6. The changes in TDI-scores and in the taste test results before and after therapy should be evaluated. Possible affecting factors like the number of chemotherapy cycles, the age, gender and smoking habits of the participants are investigated.

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Organizational Data

  •   DRKS00003361
  •   2011/11/29
  •   [---]*
  •   yes
  •   Approved
  •   837.296.03 (3958), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C10.8 -  Malignant neoplasm: Overlapping lesion of oropharynx
  •   C32.8 -  Malignant neoplasm: Overlapping lesion of larynx
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Interventions/Observational Groups

  •   The sense of smell and taste is evaluated in all participants before and after each cycle of chemotherapy using the Sniffin´ Sticks test and the whole mouth test.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Changes in the TDI-score are measured before and after each cyclus of chemotherapy using the Sniffin´ Sticks test.

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Secondary Outcome

Change in subscores (threshold, discrimination, identification) are measured before and after each cyclus of chemotherapy using the Sniffin´ Sticks test.
Changes in the sense of taste are measure before and after each cyclus of chemotherapy using the whole mouth test.
The influence of age, gender, smoking habits and duration of therapy on the results are investigated in the model.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2013/05/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Head and neck squamous cell carcinoma, informed consent

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Exclusion Criteria

Olfactory disorders as a result of a chronic rhinosinusitis, head trauma, neurodegenerative disease, inability to give informed consent

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Addresses

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    • Hals-, Nasen-, Ohrenheilklinik der Universitätsmedizin Mainz
    • Mr.  Dr. med.  Boris  Haxel 
    • Langenbesckstr. 1
    • 55131  Mainz
    • Germany
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    • Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- Hals-Chirurgie der Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Mr.  Dr.med.  Boris  Haxel 
    • Langenbesckstr. 1
    • 55131  Mainz
    • Germany
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    • Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- Hals-Chirurgie der Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Mr.  Dr.med.  Boris  Haxel 
    • Langenbesckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- Hals-Chirurgie der Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Mr.  Dr.med.  Boris  Haxel 
    • Langenbesckstr. 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/02
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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.