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Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades (SUPPORT)

Primary Purpose

Pain

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ECA
Standard topical treatment of the institution, e.g. Lotio
Sponsored by
National Center for Tumor Diseases, Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Painful cetuximab-induced rhagades, Radioimmunotherapy, Head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Heidelberg Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ECA: Ethyl-2-cyanoacrate

Standard treatment of the institution

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Evaluation of QoL
Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI)

Full Information

First Posted
September 18, 2012
Last Updated
September 22, 2017
Sponsor
National Center for Tumor Diseases, Heidelberg
Collaborators
Heidelberg University, iOMEDICO AG
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1. Study Identification

Unique Protocol Identification Number
NCT01693159
Brief Title
Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades
Acronym
SUPPORT
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Tumor Diseases, Heidelberg
Collaborators
Heidelberg University, iOMEDICO AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Painful cetuximab-induced rhagades, Radioimmunotherapy, Head and neck cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECA: Ethyl-2-cyanoacrate
Arm Type
Experimental
Arm Description
Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades
Arm Title
Standard treatment of the institution
Arm Type
Active Comparator
Arm Description
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Intervention Type
Device
Intervention Name(s)
ECA
Other Intervention Name(s)
Ethyl-2-cyanoacrylate (ECA)
Intervention Description
In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).
Intervention Type
Other
Intervention Name(s)
Standard topical treatment of the institution, e.g. Lotio
Other Intervention Name(s)
Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment
Intervention Description
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Primary Outcome Measure Information:
Title
pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)
Description
pain intensity quantified by the visual analogue scale (VAS)
Time Frame
24 hours after application
Secondary Outcome Measure Information:
Title
Evaluation of QoL
Description
Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI)
Time Frame
5 to 7 days after application of treatment
Other Pre-specified Outcome Measures:
Title
SUPO-Score for classification of cetuximab-induced rhagades
Description
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
Time Frame
24 hours and 5 to 7 days after application of treatment
Title
Adverse Events of ECA
Description
Adverse Events of ECA due to NCI CTCAE v. 4.02
Time Frame
from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Potthoff, Dr.
Phone
+496221568201
Email
karin.potthoff@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Indorf, Dr.
Phone
+497611524257
Email
martin.indorf@iomedico.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Potthoff, MD
Organizational Affiliation
National Center for Tumor Diseases, Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Heidelberg Medical Center
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Potthoff, MD
Phone
+496221568201
Email
karin.potthoff@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Matthias Haefner, MD
Phone
+496221568201
Email
matthias.haefner@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Karin Potthoff, MD
First Name & Middle Initial & Last Name & Degree
Matthias Haefner, MD
First Name & Middle Initial & Last Name & Degree
Juergen Debus, Prof. Dr. Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
24742019
Citation
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.
Results Reference
derived

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Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades

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