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Trial Title:
Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades
NCT ID:
NCT01693159
Condition:
Pain
Conditions: Official terms:
Head and Neck Neoplasms
Ethyl 2-cyanoacrylate
Conditions: Keywords:
Painful cetuximab-induced rhagades
Radioimmunotherapy
Head and neck cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
ECA
Description:
In the experimental arm patients will be topically treated with the liquid glue
ethyl-2-cyanoacrylate (ECA).
Arm group label:
ECA: Ethyl-2-cyanoacrate
Other name:
Ethyl-2-cyanoacrylate (ECA)
Intervention type:
Other
Intervention name:
Standard topical treatment of the institution, e.g. Lotio
Description:
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Arm group label:
Standard treatment of the institution
Other name:
Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment
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:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Heidelberg Medical Center
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Karin Potthoff, MD
Phone:
+496221568201
Email:
karin.potthoff@med.uni-heidelberg.de
Contact backup:
Last name:
Matthias Haefner, MD
Phone:
+496221568201
Email:
matthias.haefner@med.uni-heidelberg.de
Investigator:
Last name:
Karin Potthoff, MD
Email:
Principal Investigator
Investigator:
Last name:
Matthias Haefner, MD
Email:
Sub-Investigator
Investigator:
Last name:
Juergen Debus, Prof. Dr. Dr.
Email:
Sub-Investigator
Start date:
May 2011
Completion date:
November 2018
Lead sponsor:
Agency:
National Center for Tumor Diseases, Heidelberg
Agency class:
Other
Collaborator:
Agency:
Heidelberg University
Agency class:
Other
Collaborator:
Agency:
iOMEDICO AG
Agency class:
Industry
Source:
National Center for Tumor Diseases, Heidelberg
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01693159
