Clinical trial NCT01693159: Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Painful cetuximab-induced rhagades
Radioimmunotherapy
Head and neck cancer
Lead sponsor: National Center for Tumor Diseases, Heidelberg
Sponsor class: OTHER
Collaborators: name: Heidelberg University
name: iOMEDICO AG
First posted: 2012-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)
timeFrame: 24 hours after application
Secondary outcomes:
measure: Evaluation of QoL
timeFrame: 5 to 7 days after application of treatment
Other outcomes:
measure: SUPO-Score for classification of cetuximab-induced rhagades
timeFrame: 24 hours and 5 to 7 days after application of treatment
measure: Adverse Events of ECA
timeFrame: from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg Medical Center
Study officials:
affiliation: National Center for Tumor Diseases, Heidelberg
name: Karin Potthoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Potthoff K, Habl G, Bruckner T, Suppan C, Hassel J, Jager D, Indorf M, Debus J. Randomized controlled 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: the support trial. BMC Cancer. 2014 Apr 17;14:270. doi: 10.1186/1471-2407-14-270.