Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care supported by a Reminder App (Arm A) | Experimental | Treatment with Standard Care supported by a Reminder App, starting at the beginning of radiotherapy. |
|
| Standard Care alone (Arm B) | Active Comparator | Treatment with Standard Care alone, starting at the beginning of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile application (reminder app) | Device | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dirk Rades, Professor | Dept. of Radiation Oncology, University of Lübeck, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Practice for Radiotherapy and Radiation Oncology | Hanover | Lower Saxony | 30449 | Germany | ||
| Dept. of Radiation Oncology, University of Lübeck |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32450921 | Derived | Rades 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| D006258 | Head and Neck Neoplasms |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
Not provided
Not provided
randomized, active-controlled, parallel-group trial
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Lübeck |
| Schleswig-Holstein |
| 23562 |
| Germany |
| Dept. of Radiation Oncology, Hospital Universitario y Politecnico La Fe, | Valencia | Valencia | Spain |
| Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute | Barakaldo | Vizcaya | Spain |
| D014947 |
| Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |