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. (see Contacts and Locations)
Verified August 2013 by National Center for Tumor Diseases, Heidelberg
Sponsor:
Collaborators:
Heidelberg University
iOMEDICO AG
Information provided by (Responsible Party):
National Center for Tumor Diseases, Heidelberg
ClinicalTrials.gov Identifier:
NCT01693159
First received: September 18, 2012
Last updated: August 26, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    Adverse Events of ECA due to NCI CTCAE v. 4.02


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Gregor Habl, MD    +496221568201    gregor.habl@med.uni-heidelberg.de   
Principal Investigator: Karin Potthoff, MD         
Sub-Investigator: Gregor Habl, 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

No publications provided by National Center for Tumor Diseases, Heidelberg

Additional 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
Study First Received: September 18, 2012
Last Updated: August 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Neoplasms by Site
Cetuximab
Ethyl 2-cyanoacrylate
Antineoplastic Agents
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014