Radiation Dermatitis, Radiation-induced Oral Mucositis
Conditions
Keywords
Head-and-neck cancer, radiotherapy, radiation dermatitis, oral mucositis, reminder app
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.
Interventions
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.
Sponsors
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
randomized, active-controlled, parallel-group trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of radiation dermatitis grade ≥2 | until 60 Gy of radiotherapy | at least moderate radiation-induced skin toxicity such as erythema and desquamation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of radiation dermatitis grade ≥2 | at the end of radiotherapy | at least moderate radiation-induced skin toxicity such as erythema and desquamation |
| Rate of radiation dermatitis grade ≥3 | at 60 Gy of radiotherapy and at the end of radiotherapy | severe radiation-induced skin toxicity such as erythema and desquamation |
| Pain score | prior to radiotherapy, weekly during radiotherapy, at 60 Gy and at the end of radiotherapy | 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. |
| Rate of radiation-induced oral mucositis grade ≥2 | at 60 Gy of radiotherapy and at the end of radiotherapy | at least moderate radiation-induced inflammation of the oral mucosa |
| Rate of radiation-induced oral mucositis grade ≥3 | at 60 Gy of radiotherapy and at the end of radiotherapy | severe radiation-induced inflammation of the oral mucosa |
Countries
Germany, Spain
Outcome results
None listed