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| Name | Class |
|---|---|
| Heidelberg University | OTHER |
| iOMEDICO AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECA: Ethyl-2-cyanoacrate | Experimental | Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades |
|
| Standard treatment of the institution | Active Comparator | Standard treatment of the institution to treat painful cetuximab-induced rhagades |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECA | Device | In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karin Potthoff, Dr. | Contact | +496221568201 | karin.potthoff@med.uni-heidelberg.de | |
| Martin Indorf, Dr. | Contact | +497611524257 | martin.indorf@iomedico.com |
| Name | Affiliation | Role |
|---|---|---|
| Karin Potthoff, MD | National Center for Tumor Diseases, Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Heidelberg Medical Center | Recruiting | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24742019 | Derived | Potthoff K, Habl G, Bruckner T, Suppan C, Hassel J, Jager D, Indorf M, Debus J. 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. BMC Cancer. 2014 Apr 17;14:270. doi: 10.1186/1471-2407-14-270. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Standard topical treatment of the institution, e.g. Lotio | Other | Standard treatment of the institution to treat painful cetuximab-induced rhagades |
|
|
| 24 hours and 5 to 7 days after application of treatment |
| 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 |
| D009369 | Neoplasms |