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

Pain Clinical Trial

— SUPPORT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01693159
• Other study ID #: Uni-HD-2010-33-40-1003
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2012
• Last updated: September 22, 2017
• Start date: May 2011
• Est. completion date: November 2018

Study information

• Verified date: September 2017
• Source: National Center for Tumor Diseases, Heidelberg
• Contact: Karin Potthoff, Dr.
• Phone: +496221568201
• Email: karin.potthoff[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Pain

Intervention

Device:
• ECA
In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).

Other:
• Standard topical treatment of the institution, e.g. Lotio
Standard treatment of the institution to treat painful cetuximab-induced rhagades

Locations

Country	Name	City	State
Germany	University of Heidelberg Medical Center	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
National Center for Tumor Diseases, Heidelberg	Heidelberg University, iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SUPO-Score for classification of cetuximab-induced rhagades	SUPO-Score for classification of cetuximab-induced rhagades: Grade 1: Rhagades without clinical symptoms; Grade 2: Painful rhagades Grade 2a: Moderate pain, no impairment of activity in the daily routine (ADL) Grade 2b: Severe pain and impairment of the activities of daily living (ADL) Grade 3: Painful, deep and spontaneously bleeding rhagades; Grade 4: Superinfection of the rhagades (detection of bacterial growth) Grade 4a: Local infection Grade 4b: Systemic infection; Grade 5: Death due to complications of the rhagades	24 hours and 5 to 7 days after application of treatment
Other	Adverse Events of ECA	Adverse Events of ECA due to NCI CTCAE v. 4.02	from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment
Primary	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	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