Clinical trial · Interventional
A Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer
RAdiotherapy RElated Skin Toxicity: a Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After the planned interim analysis, the study was terminated. The start of the trial was delayed due to data protection issues and the Covid-19 pandemic. Moreover, accrual was slower than expected. Finally, funding has expired.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Dermatitis | — | UNRESOLVED | — |
| Radiation-induced Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mobile application (reminder app) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard Care supported by a Reminder App (Arm A)
- description
- Treatment with Standard Care supported by a Reminder App, starting at the beginning of radiotherapy.
- interventionNames
- Device: mobile application (reminder app)
- type
- ACTIVE_COMPARATOR
- label
- Standard Care alone (Arm B)
- description
- Treatment with Standard Care alone, starting at the beginning of radiotherapy.
- interventionNames
- Device: mobile application (reminder app)
Primary outcomes (1)
- measure
- Rate of radiation dermatitis grade ≥2
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRades D, Narvaez CA, Doemer C, Janssen S, Olbrich D, Tvilsted S, Conde-Moreno AJ, Cacicedo J. Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis. Trials. 2020 May 25;21(1):424. doi: 10.1186/s13063-020-04307-0. PMID 32450921