An interventional study of mobile application (reminder app) in Radiation Dermatitis and Radiation-induced Oral Mucositis, sponsored by University Hospital Schleswig-Holstein. Terminated at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by University Hospital Schleswig-Holstein · Not applicable, Interventional, and Prevention
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 60 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with Standard Care supported by a Reminder App, starting at the beginning of radiotherapy.
Device: mobile application (reminder app)
Treatment with Standard Care alone, starting at the beginning of radiotherapy.
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.
Rate of radiation dermatitis grade ≥2
at least moderate radiation-induced skin toxicity such as erythema and desquamation
Time frame: until 60 Gy of radiotherapy
Rate of radiation dermatitis grade ≥2
at least moderate radiation-induced skin toxicity such as erythema and desquamation
Time frame: at the end of radiotherapy
Rate of radiation dermatitis grade ≥3
severe radiation-induced skin toxicity such as erythema and desquamation
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: at 60 Gy of radiotherapy and at the end of radiotherapy
Plan to share: No
This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Schleswig-Holstein