Pain
Conditions
Keywords
Painful cetuximab-induced rhagades, Radioimmunotherapy, Head and neck cancer
Brief 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.
Interventions
DEVICEECA
In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).
OTHERStandard topical treatment of the institution, e.g. Lotio
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Sponsors
Heidelberg University
iOMEDICO AG
National Center for Tumor Diseases, Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS) | 24 hours after application | pain intensity quantified by the visual analogue scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of QoL | 5 to 7 days after application of treatment | Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI) |
Other
| Measure | Time frame | Description |
|---|---|---|
| SUPO-Score for classification of cetuximab-induced rhagades | 24 hours and 5 to 7 days after application of treatment | 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 |
| Adverse Events of ECA | from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment | Adverse Events of ECA due to NCI CTCAE v. 4.02 |
Countries
Germany
Contacts
Primary ContactKarin Potthoff, Dr.
Backup ContactMartin Indorf, Dr.
Outcome results
None listed