Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005537

Trial Description

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Title

Randomized Controlled Multicenter Trial to Evaluate the Effects of Ethyl-2-cyanoacrylate on Pain Intensity and Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades During Radioimmunotherapy

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Trial Acronym

SUPPORT

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URL of the Trial

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Brief Summary in Lay Language

The SUPPORT trial is an open-label, prospective, randomized, national multicenter
intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the
standard treatment of each institution on the pain intensity and QoL in patients with
locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades
during radioimmunotherapy.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005537
  •   2014/06/04
  •   2012/09/18
  •   yes
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Secondary IDs

  •   NCT01693159  (ClinicalTrials.gov)
  •   Uni-HD-2010-33-40-1003  (National Center for Tumor Diseases, Heidelberg)
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Health Condition or Problem studied

  •   Pain
  •   R52.9 -  Pain, unspecified
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Interventions/Observational Groups

  •   Device: ECA
  •   Other: Standard topical treatment of the institution, e.g. Lotio
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Crossover
  •   N/A
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Primary Outcome

- pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS); time frame: 24 hours after application; pain intensity quantified by the visual analogue scale (VAS)

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Secondary Outcome

- Evaluation of QoL; time frame: 5 to 7 days after application of treatment; Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/05/31
  •   50
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Inclusion Criteria

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

- Locally advanced squamous cell carcinoma of the head and neck and participation in
the HICARE-phase-IV-trial

- Cetuximab-induced painful rhagades, i.e. SUPO Score 2-3 (see Figure 2)

- Compliance to the photo documentation

- Ability of subject to understand character and individual consequences of the
clinical trial

- Written informed consent

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Exclusion Criteria

- Cetuximab-induced rhagades without any pain, i.e. SUPO Score 1

- Cetuximab-induced rhagades, SUPO Score 4, i.e. superinfection of the rhagades

- Patients not being enrolled in the HICARE trial

- Substance misuse, psychoactive substance abuse or psychological/social conditions
leading to a decreased patients' compliance with possible bad influence to the
results of the study

- Known allergic reaction to ethyl-2-cyanoacrylate (ECA)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • National Center for Tumor Diseases, Heidelberg
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    • University of Heidelberg
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    • iOMEDICO AG
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    • National Center for Tumor Diseases, Heidelberg
    • Karin Potthoff, MD 
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    • Karin Potthoff, Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.