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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Pain

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)

Outcome Description:

pain intensity quantified by the visual analogue scale (VAS)

Outcome Time Frame:

24 hours after application

Safety Issue:

No

Principal Investigator

Karin Potthoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Center for Tumor Diseases, Heidelberg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Uni-HD-2010-33-40-1003

NCT ID:

NCT01693159

Start Date:

May 2011

Completion Date:

October 2013

Related Keywords:

  • Pain
  • Painful cetuximab-induced rhagades
  • Radioimmunotherapy
  • Head and neck cancer
  • Head and Neck Neoplasms
  • Stress, Psychological

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