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
Karin Potthoff, Dr. Kontakt: Phone: +496221568201 E-Mail: karin.potthoff@med.uni-heidelberg.de» Kontaktdaten anzeigen Martin Indorf, Dr. Kontakt: Phone: +497611524257 E-Mail: martin.indorf@iomedico.com» Kontaktdaten anzeigen
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
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.
- 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)
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)
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
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades"
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