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

September 22, 2017 updated by: National Center for Tumor Diseases, Heidelberg

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECA: Ethyl-2-cyanoacrate
Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades
Device: ECA
In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).
Other Names:
  • Ethyl-2-cyanoacrylate (ECA)
Active Comparator: Standard treatment of the institution
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Other: Standard topical treatment of the institution, e.g. Lotio
Standard treatment of the institution to treat painful cetuximab-induced rhagades
Other Names:
  • Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours after application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of QoL
Time Frame: 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)
5 to 7 days after application of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUPO-Score for classification of cetuximab-induced rhagades
Time Frame: 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
24 hours and 5 to 7 days after application of treatment
Adverse Events of ECA
Time Frame: 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
from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Tumor Diseases, Heidelberg

Collaborators

Heidelberg University
iOMEDICO AG

Investigators

  • Principal Investigator: Karin Potthoff, MD, National Center for Tumor Diseases, Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-HD-2010-33-40-1003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on ECA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe