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JOURNAL ONKOLOGIE – STUDIE
SUPPORT

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

Rekrutierend

NCT-Nummer:
NCT01693159

Studienbeginn:
Mai 2011

Letztes Update:
25.09.2017

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
National Center for Tumor Diseases, Heidelberg

Collaborator:
Heidelberg University, iOMEDICO AG,

Studienleiter

Karin Potthoff, MD
Principal Investigator
National Center for Tumor Diseases, Heidelberg

Kontakt

Studienlocations
(1 von 1)

University of Heidelberg Medical Center
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Karin Potthoff, MD
Phone: +496221568201
E-Mail: karin.potthoff@med.uni-heidelberg.de

Matthias Haefner, MD
Phone: +496221568201
E-Mail: matthias.haefner@med.uni-heidelberg.de
» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. 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:

1. 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)

Studien-Arme

  • Experimental: ECA: Ethyl-2-cyanoacrate
    Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades
  • Active Comparator: Standard treatment of the institution
    Standard treatment of the institution to treat painful cetuximab-induced rhagades

Geprüfte Regime

  • ECA (Ethyl-2-cyanoacrylate (ECA)):
    In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).
  • Standard topical treatment of the institution, e.g. Lotio (Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment):
    Standard treatment of the institution to treat painful cetuximab-induced rhagades

Quelle: ClinicalTrials.gov


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