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

Abstract

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 60 Gy 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 60 Gy 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 patients with head-and-neck cancer during radiotherapy. Trial registration clinicaltrials.gov (NCT04110977). Registered on September 27, 2019. First patient is planned to be included in December 2019.

Efficacy of different plant extracts in the prevention of radiation dermatitis in radiotherapy patients with nasopharyngeal carcinoma

“…Radiation dermatitis is an inflammatory reaction of skin and mucosa and caused by β-ray, γ-ray, and x-ray. [ 9 , 10 ] Skin is one of the tissues with moderate sensitivity to radiation. The mechanism of skin radiation injury is the reflex dilatation of capillaries in the radiation field, thus resulting in local congestive reaction, erythema, vascular injury, microcirculation disturbance, and even the formation of skin ulcers.…”

Impact of a mobile application (reminder app) on acute toxicity during radiotherapy of head-and-neck cancer – results of a randomized phase III trial (RAREST-02)

“…To be included, patients were required to have histologically proven SCCHN and to be able to use a smartphone. The complete inclusion and exclusion criteria were described in a previous article [ 6 ]. After randomization, patients were excluded from the per-protocol-set and the analyses, if they received less than 60 Gy and the reason for discontinuation of radiotherapy was not death, dermatitis or oral mucositis.…”

“…In the 53 patients included in the per-protocol-set, radiotherapy was performed as volumetric modulated arc therapy (VMAT) with conventional fractionation (2.0 Gy per fraction on five consecutive days per week). Further details of radiotherapy were previously reported [ 6 ]. Forty-one patients received upfront resection of the primary tumor plus dissection of loco-regional lymph nodes.…”

“…According to sample size calculations, 168 patients should be randomized including 5% of patients not qualifying for analyses to achieve a statistical power of 80%. Details of these calculations were previously reported [ 6 ]. The experimental and the control group were compared with respect to distributions of baseline characteristics and the rates of radiation dermatitis and oral mucositis using the Chi-square test or the Fisher’s exact test, if the expected frequency in a two-by-two table was < 5 in at least one cell.…”

Impact of Dose-Volume Parameters of Parotid Glands on Xerostomia in Patients Irradiated for Head-and-Neck Cancer

“…It is often associated with significant toxicity, particularly if administered with concurrent systemic treatment. Acute toxicity includes radiation dermatitis and oral mucositis that usually resolve within a few weeks (2)(3)(4). In contrast, late toxicity frequently persists for several years or even for the entire lifespan (5).…”