Clinical trial · Interventional
Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ECA | Device | — | UNRESOLVED |
| Standard topical treatment of the institution, e.g. Lotio | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ECA: Ethyl-2-cyanoacrate
- description
- Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades
- interventionNames
- Device: ECA
- type
- ACTIVE_COMPARATOR
- label
- Standard treatment of the institution
- description
- Standard treatment of the institution to treat painful cetuximab-induced rhagades
- interventionNames
- Other: Standard topical treatment of the institution, e.g. Lotio
Primary outcomes (1)
- measure
- pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDPotthoff 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. PMID 24742019