Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades
Conditions
Pain
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Painful cetuximab-induced rhagades, Radioimmunotherapy, Head and neck cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ECA Type: Device
Name: Standard topical treatment of the institution, e.g. Lotio Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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)
Location
University of Heidelberg Medical Center
Heidelberg, Germany
Status: Recruiting
Contact: Karin Potthoff, MD - +496221568201 - karin.potthoff@med.uni-heidelberg.de
Start Date
May 2011
Completion Date
November 2016
Sponsors
National Center for Tumor Diseases, Heidelberg
Source
National Center for Tumor Diseases, Heidelberg
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page