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Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades (SUPPORT)

This study is currently recruiting participants.
Verified September 2017 by National Center for Tumor Diseases, Heidelberg
Sponsor:
ClinicalTrials.gov Identifier:
NCT01693159
First Posted: September 26, 2012
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Heidelberg University
iOMEDICO AG
Information provided by (Responsible Party):
National Center for Tumor Diseases, Heidelberg
  Purpose
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.

Condition Intervention
Pain Device: ECA Other: Standard topical treatment of the institution, e.g. Lotio

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by National Center for Tumor Diseases, Heidelberg:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • SUPO-Score for classification of cetuximab-induced rhagades [ Time Frame: 24 hours and 5 to 7 days after application of treatment ]

    SUPO-Score for classification of cetuximab-induced rhagades:

    Grade 1: Rhagades without clinical symptoms

    Grade 2: Painful rhagades Grade 2a: Moderate pain, no impairment of activity in the daily routine (ADL) Grade 2b: Severe pain and impairment of the activities of daily living (ADL) Grade 3: Painful, deep and spontaneously bleeding rhagades

    Grade 4: Superinfection of the rhagades (detection of bacterial growth) Grade 4a: Local infection Grade 4b: Systemic infection

    Grade 5: Death due to complications of the rhagades


  • Adverse Events of ECA [ Time Frame: from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment ]
    Adverse Events of ECA due to NCI CTCAE v. 4.02


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECA: Ethyl-2-cyanoacrate
Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades
Device: ECA
In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).
Other Name: Ethyl-2-cyanoacrylate (ECA)
Active Comparator: Standard treatment of the institution
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Other: Standard topical treatment of the institution, e.g. Lotio
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Other Name: Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693159


Contacts
Contact: Karin Potthoff, Dr. +496221568201 karin.potthoff@med.uni-heidelberg.de
Contact: Martin Indorf, Dr. +497611524257 martin.indorf@iomedico.com

Locations
Germany
University of Heidelberg Medical Center Recruiting
Heidelberg, Germany, 69120
Contact: Karin Potthoff, MD    +496221568201    karin.potthoff@med.uni-heidelberg.de   
Contact: Matthias Haefner, MD    +496221568201    matthias.haefner@med.uni-heidelberg.de   
Principal Investigator: Karin Potthoff, MD         
Sub-Investigator: Matthias Haefner, MD         
Sub-Investigator: Juergen Debus, Prof. Dr. Dr.         
Sponsors and Collaborators
National Center for Tumor Diseases, Heidelberg
Heidelberg University
iOMEDICO AG
Investigators
Principal Investigator: Karin Potthoff, MD National Center for Tumor Diseases, Heidelberg
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Center for Tumor Diseases, Heidelberg
ClinicalTrials.gov Identifier: NCT01693159     History of Changes
Other Study ID Numbers: Uni-HD-2010-33-40-1003
First Submitted: September 18, 2012
First Posted: September 26, 2012
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by National Center for Tumor Diseases, Heidelberg:
Painful cetuximab-induced rhagades
Radioimmunotherapy
Head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Ethyl 2-cyanoacrylate
Antineoplastic Agents
Hemostatics
Coagulants