NCT01693159

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

7.2 years

First QC Date

September 18, 2012

Last Update Submit

September 22, 2017

Conditions

Pain

Keywords

Painful cetuximab-induced rhagadesRadioimmunotherapyHead and neck cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation of QoL

    5 to 7 days after application of treatment

Other Outcomes (2)

  • SUPO-Score for classification of cetuximab-induced rhagades

    24 hours and 5 to 7 days after application of treatment

  • Adverse Events of ECA

    from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment

Study Arms (2)

ECA: Ethyl-2-cyanoacrate

EXPERIMENTAL

Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades

Device: ECA

Standard treatment of the institution

ACTIVE COMPARATOR

Standard treatment of the institution to treat painful cetuximab-induced rhagades

Other: Standard topical treatment of the institution, e.g. Lotio

Interventions

ECADEVICE

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

Also known as: Ethyl-2-cyanoacrylate (ECA)
ECA: Ethyl-2-cyanoacrate
Standard topical treatment of the institution, e.g. LotioOTHER

Standard treatment of the institution to treat painful cetuximab-induced rhagades

Also known as: Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment
Standard treatment of the institution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg Medical Center

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24742019DERIVED

MeSH Terms

Conditions

PainHead and Neck Neoplasms

Interventions

Ointments

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Karin Potthoff, MD

    National Center for Tumor Diseases, Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Potthoff, Dr.

CONTACT

+496221568201karin.potthoff@med.uni-heidelberg.de

Martin Indorf, Dr.

CONTACT

+497611524257martin.indorf@iomedico.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2012

First Posted

September 26, 2012

Study Start

May 1, 2011

Primary Completion

July 1, 2018

Study Completion

November 1, 2018

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

DE(1)