A Reminder App to Reduce Radiation Dermatitis Rates in Patients With Head-and-Neck Cancer

Radiation Dermatitis Clinical Trial

— RAREST-02  

Official title:

RAdiotherapy RElated Skin Toxicity: A Reminder App to Reduce Radiation Dermatitis Rates in Patients With Head-and-Neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110977
• Other study ID #: RAREST-02
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: November 2021

Study information

• Verified date: November 2020
• Source: University Hospital Schleswig-Holstein
• Contact: Dirk Rades, Professor
• Phone: +49 451 500
• Email: dirk.rades[@]uksh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). The primary endpoint is the rate of patients experiencing grade ≥2 radiation dermatitis at 60 Gy of radiotherapy. 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. If the addition of a reminder app to standard care will result in a significant reduction of radiation toxicity, it could become a helpful tool for these patients.

Description:

The goal of this trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).

This is a randomized, active-controlled, parallel-group trial, which will compare the following treatments of radiation dermatitis (primary endpoint) and oral mucositis in patients with SCCHN: Standard care supported by a reminder app (Arm A) vs. standard care alone (Arm B). The primary endpoint is to investigate the rate of patients experiencing grade ≥2 radiation dermatitis at 60 Gy of radiotherapy, the minimum planned total dose for all patients receiving definitive or adjuvant radiotherapy for locally advanced SCCHN with curative intention. In addition, the following endpoints will be evaluated: Radiation dermatitis grade ≥2 at the end of radiation treatment (EOT), radiation dermatitis grade ≥3 at 60 Gy and EOT, quality of life, pain, and radiation-induced oral mucositis grade ≥2 and grade ≥3 at 60 Gy and at EOT. According to sample size calculations, 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. The impact of the reminder app will be considered clinically relevant, if the rate of grade ≥2 radiation dermatitis can be reduced from 85% to 65%.

If the addition of a reminder app to standard care will result in a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for patients during radiotherapy of for SCCHN.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven squamous cell carcinoma of the head-and-neck (SCCHN)

• Indication for definitive or adjuvant radio(chemo)therapy

• Possession of and ability to use a smart phone

• Age =18 years

• Written informed consent

• Capacity of the patient to contract

Exclusion Criteria:

• Nasopharynx cancer

• Pregnancy, Lactation

• Treatment with epidermal growth factor receptor (EGFR)-antibodies (either given or planned)

• Expected non-compliance

Related Conditions & MeSH terms

• Dermatitis
• Head and Neck Neoplasms
• Mucositis
• Radiation Dermatitis
• Radiation-induced Oral Mucositis
• Radiodermatitis
• Stomatitis

Intervention

Device:
• mobile application (reminder app)
This app will remind the patients four times a day to perform skin and mouth care. Instructions are given how to properly perform skin and mouth care. The patients may postpone each required care procedure for up to 2 hours. Finally, the patients are asked to state for each procedure whether or not they performed it. To increase the patients' motivation, they will earn points for each successfully performed care procedure.

Locations

Country	Name	City	State
Germany	Medical Practice for Radiotherapy and Radiation Oncology	Hannover	Niedersachsen
Germany	Dept. of Radiation Oncology, University of Lübeck	Lübeck	Schleswig-Holstein
Spain	Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute	Barakaldo	Vizcaya
Spain	Dept. of Radiation Oncology, Hospital Universitario y Politecnico La Fe,	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of radiation dermatitis grade =2	at least moderate radiation-induced skin toxicity such as erythema and desquamation	until 60 Gy of radiotherapy
Secondary	Rate of radiation dermatitis grade =2	at least moderate radiation-induced skin toxicity such as erythema and desquamation	at the end of radiotherapy
Secondary	Rate of radiation dermatitis grade =3	severe radiation-induced skin toxicity such as erythema and desquamation	at 60 Gy of radiotherapy and at the end of radiotherapy
Secondary	Pain score	Pain within the radiation fields measured with a self-rating analogue scale ranging from 0 (no pain) to 10 (maximum pain) points; higher values represent worse outcomes.	prior to radiotherapy, weekly during radiotherapy, at 60 Gy and at the end of radiotherapy
Secondary	Rate of radiation-induced oral mucositis grade =2	at least moderate radiation-induced inflammation of the oral mucosa	at 60 Gy of radiotherapy and at the end of radiotherapy
Secondary	Rate of radiation-induced oral mucositis grade =3	severe radiation-induced inflammation of the oral mucosa	at 60 Gy of radiotherapy and at the end of radiotherapy