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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Device: ECA
* Other: Standard topical treatment of the institution, e.g. Lotio


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECA: Ethyl-2-cyanoacrate<br>Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades | Device: ECA<br>* In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).<br>* Other names: Ethyl-2-cyanoacrylate (ECA);|
| Active Comparator: Standard treatment of the institution<br>Standard treatment of the institution to treat painful cetuximab-induced rhagades | Other: Standard topical treatment of the institution, e.g. Lotio<br>* Standard treatment of the institution to treat painful cetuximab-induced rhagades<br>* Other names: Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 24 hours after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of QoL | Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI) | 5 to 7 days after application of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Painful cetuximab-induced rhagades, Radioimmunotherapy, Head and neck cancer