PainSUPPORTNCT01693159
Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades
A study testing ECA and Standard topical treatment of the institution, e.g. Lotio in people with Pain, run by National Center for Tumor Diseases, Heidelberg at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- ECA and Standard topical treatment of the institution, e.g. Lotio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg Medical Center
Heidelberg, 69120
Karin Potthoff, MD, +496221568201, karin.potthoff@med.uni-heidelberg.de
Matthias Haefner, MD, +496221568201, matthias.haefner@med.uni-heidelberg.de
About this study
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
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.
- Conditions
- Pain
- Being tested
- ECA, Standard topical treatment of the institution, e.g. Lotio
- Keywords
- Painful cetuximab-induced rhagades, Radioimmunotherapy, Head and neck cancer
- Medical subject headings
- Pain, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECADevice
Also called Ethyl-2-cyanoacrylate (ECA)
In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).
Standard topical treatment of the institution, e.g. LotioOther
Also called Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment
Standard treatment of the institution to treat painful cetuximab-induced rhagades
| Study group | Role | What they receive |
|---|---|---|
| ECA: Ethyl-2-cyanoacrate | Experimental | Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades Receives: Device: ECA |
| Standard treatment of the institution | Active comparator | Standard treatment of the institution to treat painful cetuximab-induced rhagades Receives: Other: Standard topical treatment of the institution, e.g. Lotio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours after application
Secondary outcomes (1)
Evaluation of QoL
Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI)
Measured: 5 to 7 days after application of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startMay 2011
- Primary completionJul 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Tumor Diseases, Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, iOMEDICO AG
- Responsible party
- Sponsor
- Investigators
- Karin Potthoff, MD, Principal investigator, National Center for Tumor Diseases, Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693159
- Sponsor's protocol ID
- Uni-HD-2010-33-40-1003
- Acronym
- SUPPORT
- Status last verified
- Sep 2017
- First submitted
- 18 Sep 2012
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24742019
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01693159
- Acronym / sponsor ID
- SUPPORT / Uni-HD-2010-33-40-1003
- Conditions
- Pain
- Keywords
- Painful cetuximab-induced rhagades, Radioimmunotherapy, Head and neck cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Center for Tumor Diseases, HeidelbergUniversity, hospital or other
- Collaborators
- Heidelberg University, iOMEDICO AG
- Study start
- May 2011
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECA: Ethyl-2-cyanoacrate | Experimental | Device: ECAApplication of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades |
| Standard treatment of the institution | Active comparator | Other: Standard topical treatment of the institution, e.g. LotioStandard treatment of the institution to treat painful cetuximab-induced rhagades |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECAAlso: Ethyl-2-cyanoacrylate (ECA)In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA). | Device | ECA: Ethyl-2-cyanoacrate |
| Standard topical treatment of the institution, e.g. LotioAlso: Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatmentStandard treatment of the institution to treat painful cetuximab-induced rhagades | Other | Standard treatment of the institution |
Primary outcome
pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)
Time frame: 24 hours after application
pain intensity quantified by the visual analogue scale (VAS)
1 secondary outcome
Evaluation of QoL
Time frame: 5 to 7 days after application of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Derived from this study: PubMed 24742019Potthoff 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Potthoff, MD principal investigator
National Center for Tumor Diseases, Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECA and Standard topical treatment of the institution, e.g. Lotio in people with Pain, run by National Center for Tumor Diseases, Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karin Potthoff, Dr. (+496221568201, karin.potthoff@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS) (time frame: 24 hours after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01693159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.