An interventional study of ECA and Standard topical treatment of the institution, e.g. Lotio in Pain, sponsored by National Center for Tumor Diseases, Heidelberg. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by National Center for Tumor Diseases, Heidelberg · Not applicable, Interventional, and Treatment
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 50 is close to the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →National Center for Tumor Diseases, Heidelberg is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades
Device: ECA
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Other: Standard topical treatment of the institution, e.g. Lotio
In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).
Also known as: Ethyl-2-cyanoacrylate (ECA)
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Also known as: Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment
pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)
pain intensity quantified by the visual analogue scale (VAS)
Time frame: 24 hours after application
Evaluation of QoL
Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI)
Time frame: 5 to 7 days after application of treatment
SUPO-Score for classification of cetuximab-induced rhagades
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
Time frame: 24 hours and 5 to 7 days after application of treatment
Adverse Events of ECA
Adverse Events of ECA due to NCI CTCAE v. 4.02
Time frame: from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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National Center for Tumor Diseases, Heidelberg