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Study protocol
Radiotherapy related skin toxicity (RAREST-02): A reminder app developed to reduce radiation dermatitis in patients with head-and-neck cancer
Dirk Rades
University of Lübeck
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Radiotherapy of head-and-neck cancer can be associated with significant toxicities including dermatitis and oral mucositis. Severe toxicities may require interruptions of the radiation treatment associated with impairment of the patients’ prognoses. This study will investigate whether the addition of a reminder app to standard care can reduce dermatitis and oral mucositis rates during radiotherapy in these patients.
Methods: This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥2 radiation dermatitis and oral mucositis at 60Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head-and-neck cancer. Moreover, radiation-induced dermatitis and oral mucositis grade ≥3 at 60Gy and both grade ≥2 and grade ≥3 at the end of radiation treatment (EOT) will be evaluated, as well as quality of life and pain. 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 rates of grade ≥2 radiation dermatitis (primary endpoint) and oral mucositis (secondary endpoint) can be reduced by 20%.
Discussion: If the addition of a reminder app to standard care will lead to a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for head-and-neck cancer patients during radiotherapy.
Trial registration: clinicaltrials.gov (NCT04110977; URL: https://clinicaltrials.gov/show/NCT04110977). Registered on 27th of September, 2019. First patient is planned to be included in December 2019.
Keywords
Head-and-neck cancer, radiotherapy, radiation dermatitis, oral mucositis, reminder app
Figure 1
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Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 20 Dec, 2019
No community comments so far
Review #3 received
Received 29 Feb, 2020
Reviewer #3 agreed
On 18 Feb, 2020
Review #1 received
Received 24 Jan, 2020
Reviewer #2 agreed
On 20 Jan, 2020
Reviewer #1 agreed
On 15 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 19 Dec, 2019
First submitted
On 04 Dec, 2019
Metrics
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Radiotherapy related skin toxicity (RAREST-02): A reminder app developed to reduce radiation dermatitis in patients with head-and-neck cancer
Dirk Rades
University of Lübeck
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 20 Dec, 2019
No community comments so far
Review #3 received
Received 29 Feb, 2020
Reviewer #3 agreed
On 18 Feb, 2020
Review #1 received
Received 24 Jan, 2020
Reviewer #2 agreed
On 20 Jan, 2020
Reviewer #1 agreed
On 15 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 19 Dec, 2019
First submitted
On 04 Dec, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Radiotherapy of head-and-neck cancer can be associated with significant toxicities including dermatitis and oral mucositis. Severe toxicities may require interruptions of the radiation treatment associated with impairment of the patients’ prognoses. This study will investigate whether the addition of a reminder app to standard care can reduce dermatitis and oral mucositis rates during radiotherapy in these patients.
Methods: This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥2 radiation dermatitis and oral mucositis at 60Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head-and-neck cancer. Moreover, radiation-induced dermatitis and oral mucositis grade ≥3 at 60Gy and both grade ≥2 and grade ≥3 at the end of radiation treatment (EOT) will be evaluated, as well as quality of life and pain. 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 rates of grade ≥2 radiation dermatitis (primary endpoint) and oral mucositis (secondary endpoint) can be reduced by 20%.
Discussion: If the addition of a reminder app to standard care will lead to a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for head-and-neck cancer patients during radiotherapy.
Trial registration: clinicaltrials.gov (NCT04110977; URL: https://clinicaltrials.gov/show/NCT04110977). Registered on 27th of September, 2019. First patient is planned to be included in December 2019.
Figure 1