Open Access Study protocol

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

Karin Potthoff13*, Gregor Habl1, Thomas Bruckner2, Christian Suppan3, Jessica Hassel4, Dirk Jäger3, Martin Indorf5 and Juergen Debus1

Author Affiliations

1 Department of Radiation Oncology, National Center for Tumor Diseases, University of Heidelberg, Heidelberg, Germany

2 Institute for Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

3 Department of Medical Oncology, National Center for Tumor Diseases, University of Heidelberg, Heidelberg, Germany

4 Department of Dermatology, National Center for Tumor Diseases, University of Heidelberg, Heidelberg, Germany

5 iOMEDICO AG, Freiburg, Germany

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BMC Cancer 2014, 14:270  doi:10.1186/1471-2407-14-270

Published: 17 April 2014

Abstract

Background

Cetuximab is a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR). Skin reactions are the most common side effects of cetuximab. Rhagades of the tips of the fingers and toes, the heels and especially the interphalangeal joints are one of the most frightening and painful dermatological side effects that may develop from EGFR-inhibitor therapy. Rhagades are characterized by pain, severe tenderness and poor healing response. They are challenging to treat. Thus, rhagades often poses the most significant threat to the quality of life (QoL) for these patients. Ethyl-2-cyanoacrylate (ECA), an ethyl ester of the 2-cyano-2-propenoic acid, is often used as adhesive in a variety of different work settings in industry, i.e. as a component in nail-care products such as nail glue. In addition, ECA is used for various medical indications, such as for liquid bandages and for suture-less surgery. Wound healing can be accelerated with ECA. The purpose of the SUPPORT trial is to investigate the efficacy of ECA for the treatment of cetuximab-induced rhagades and to assess the clinical usefulness of the SUPO score, a new classification system for rhagades induced by EGFR-inhibitor therapy.

Methods/Design

The SUPPORT trial is an open-label, prospective, randomized, national multicenter intervention study to evaluate the effectiveness of ECA 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. Primary endpoint is the assessment of the pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS). Secondary endpoints are the evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI).

Discussion

During treatment with EGFR inhibitors it is necessary to recognize and manage side effects promptly to assure better patient QoL. The SUPPORT trial is the first randomized clinical trial evaluating a new treatment option for painful cetuximab-induced rhagades. Furthermore, the new SUPO score will be prospectively assessed in terms of clinical usefulness for classification of EGFR inhibitor-induced rhagades.

Trial registration

Current Controlled Trials NCT01693159.