Radiation DermatitisRAREST-02NCT04110977
A Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer
A study testing mobile application (reminder app) in people with Radiation Dermatitis and Radiation-induced Oral Mucositis, run by University Hospital Schleswig-Holstein at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Dermatitis, Radiation-induced Oral Mucositis
- What is being tested?
- mobile application (reminder app)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Oct 2020to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nasopharynx cancer
- Pregnancy, Lactation
- Treatment with epidermal growth factor receptor (EGFR)-antibodies (either given or planned)
- Expected non-compliance
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Medical Practice for Radiotherapy and Radiation Oncology
Hanover, Lower Saxony, 30449
Dept. of Radiation Oncology, University of Lübeck
Lübeck, Schleswig-Holstein, 23562
Spain2 sites
Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute
Barakaldo, Vizcaya
Dept. of Radiation Oncology, Hospital Universitario y Politecnico La Fe,
Valencia, Valencia
About this study
Official title: RAdiotherapy RElated Skin Toxicity: a Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer
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.
Read the 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.
- Being tested
- mobile application (reminder app)
- Keywords
- Head-and-neck cancer, radiotherapy, radiation dermatitis, oral mucositis, reminder app
- Medical subject headings
- Radiodermatitis, Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: mobile application (reminder app) |
| Standard Care alone (Arm B) | Active comparator | Treatment with Standard Care alone, starting at the beginning of radiotherapy. Receives: Device: mobile application (reminder app) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of radiation dermatitis grade ≥2
at least moderate radiation-induced skin toxicity such as erythema and desquamation
Measured: until 60 Gy of radiotherapy
Secondary outcomes (5)
Rate of radiation dermatitis grade ≥2
at least moderate radiation-induced skin toxicity such as erythema and desquamation
Measured: at the end of radiotherapy
Rate of radiation dermatitis grade ≥3
severe radiation-induced skin toxicity such as erythema and desquamation
Measured: 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.
Measured: 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
Measured: 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
Measured: at 60 Gy of radiotherapy and at the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start10 Oct 2020
- Primary completion17 Jan 2022
- Study completion5 Dec 2022
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, active-controlled, parallel-group trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dirk Rades, University Hospital Schleswig-Holstein
- Investigators
- Dirk Rades, Professor, Principal investigator, Dept. of Radiation Oncology, University of Lübeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110977
- Sponsor's protocol ID
- RAREST-02
- Acronym
- RAREST-02
- Status last verified
- Dec 2022
- First submitted
- 27 Sep 2019
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32450921
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAdiotherapy RElated Skin Toxicity: a Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer
- ClinicalTrials.gov ID
- NCT04110977
- Acronym / sponsor ID
- RAREST-02 / RAREST-02
- Keywords
- Head-and-neck cancer, radiotherapy, radiation dermatitis, oral mucositis, reminder app
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, active-controlled, parallel-group trial
| Arm | Type | Receives |
|---|---|---|
| Standard Care supported by a Reminder App (Arm A) | Experimental | Device: mobile application (reminder app)Treatment with Standard Care supported by a Reminder App, starting at the beginning of radiotherapy. |
| Standard Care alone (Arm B) | Active comparator | Device: mobile application (reminder app)Treatment with Standard Care alone, starting at the beginning of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Nasopharynx cancer
- Pregnancy, Lactation
- Treatment with epidermal growth factor receptor (EGFR)-antibodies (either given or planned)
- Expected non-compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Standard Care alone (Arm B), Standard Care supported by a Reminder App (Arm A) |
Primary outcome
Rate of radiation dermatitis grade ≥2
Time frame: until 60 Gy of radiotherapy
at least moderate radiation-induced skin toxicity such as erythema and desquamation
5 secondary outcomes
Rate of radiation dermatitis grade ≥2
Time frame: at the end of radiotherapy
Rate of radiation dermatitis grade ≥3
Time frame: at 60 Gy of radiotherapy and at the end of radiotherapy
Pain score
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
Time frame: at 60 Gy of radiotherapy and at the end of radiotherapy
Rate of radiation-induced oral mucositis grade ≥3
Time frame: at 60 Gy of radiotherapy and at the end of radiotherapy
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 32450921Rades 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Rades, Professor principal investigator
Dept. of Radiation Oncology, University of Lübeck, Germany
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile application (reminder app) in people with Radiation Dermatitis and Radiation-induced Oral Mucositis, run by University Hospital Schleswig-Holstein at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of radiation dermatitis grade ≥2 (time frame: until 60 Gy of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04110977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.