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

National Center for Tumor Diseases, Heidelberg

Status: Unknown

Conditions: Pain

Treatments: Other: Standard topical treatment of the institution, e.g. Lotio; Device: ECA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01693159

Uni-HD-2010-33-40-1003

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

ECA: Ethyl-2-cyanoacrate

Experimental group

Description:

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

Treatment:

Device: ECA

Standard treatment of the institution

Active Comparator group

Description:

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

Treatment:

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