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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Radiation Dermatitis, Radiation-induced Oral Mucositis

Intervention / Treatment
-----------------
* Device: mobile application (reminder app)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, active-controlled, parallel-group trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Care supported by a Reminder App (Arm A)<br>Treatment with Standard Care supported by a Reminder App, starting at the beginning of radiotherapy. | Device: mobile application (reminder app)<br>* 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.<br>|
| Active Comparator: Standard Care alone (Arm B)<br>Treatment with Standard Care alone, starting at the beginning of radiotherapy. | Device: mobile application (reminder app)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of radiation dermatitis grade ≥2 | at least moderate radiation-induced skin toxicity such as erythema and desquamation | until 60 Gy of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of radiation dermatitis grade ≥2 | at least moderate radiation-induced skin toxicity such as erythema and desquamation | at the end of radiotherapy | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head-and-neck cancer, radiotherapy, radiation dermatitis, oral mucositis, reminder app