A randomized trial (RAREST-01) comparing Mepitel® Film and standard care for prevention of radiation dermatitis in patients irradiated for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN)

Rades, Dirk; Narvaez, Carlos A; SPLETTSTÖSSER, LAURA; Dömer, Claudia; Setter, Cornelia; Idel, Christian; Ribbat‐Idel, Julika; Perner, Sven; Bartscht, Tobias; Olbrich, Denise; Schild, Steven E.; Carl, Jesper

doi:10.1016/j.radonc.2019.07.023

Cited by 29 publications

(35 citation statements)

References 23 publications

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“…20 An earlier trial using Mepilex Lite, a non-transparent dressing with a foam layer, reported that this dressing decreased time to healing of moist desquamation and improved sleep quality in 88 patients with nasopharyngeal carcinoma. 30 RISRAS is a very sensitive scale for measuring radiation-induced skin reactions, as it measures skin reaction severity on a scale of 0-36 ( Fig. 1), whereas RTOG grades skin reaction severity on a scale of 0-4.…”

Section: Discussionmentioning

confidence: 99%

Mepitel Film is superior to Biafine cream in managing acute radiation‐induced skin reactions in head and neck cancer patients: a randomised intra‐patient controlled clinical trial

Yan

Yuan

Wang

et al. 2020

J of Medical Radiation Sci

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Introduction We previously showed that Mepitel Film decreased the severity of acute radiation‐induced skin reactions in head and neck cancer patients. In the current study, we compared the effect of Mepitel Film and Biafine cream on skin reaction severity in a larger cohort of head and neck cancer patients. Methods A total of 44 head and neck cancer patients were recruited with 39 patients contributing full data sets for analysis. Patients received a dose of 50 Gy in 25 fractions to the bilateral lymph nodes in the neck. Left and right lymph node areas were randomised to either Mepitel Film or Biafine cream, applied prophylactically. Skin reaction severity was measured using Radiation‐Induced Skin Reaction Assessment Scale (RISRAS) and expanded Radiation Oncology group (RTOG) grades. Skin dose was measured using gafchromic Film. Results Skin reaction severity (combined RISRAS score) underneath Mepitel Film was decreased by 30% (P < 0.001) and moist desquamation rates by 41% (P < 0.001). Skin dose underneath Mepitel Film and Biafine cream was similar (P = 0.925) and unlikely to have affected skin reaction severity. The vast majority (80%) of patients preferred Mepitel Film over Biafine cream. Negative aspects of Mepitel Film included poor adherence (11/39) and discomfort (16/39) during hot weather and showering and itchy skin underneath Mepitel Film (12/39). Conclusions Mepitel Film was superior to Biafine cream in reducing the severity of acute radiation‐induced skin reactions and moist desquamation incidence in our head and neck patient cohort.

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Section: Discussionmentioning

confidence: 99%

Mepitel Film is superior to Biafine cream in managing acute radiation‐induced skin reactions in head and neck cancer patients: a randomised intra‐patient controlled clinical trial

Yan

Yuan

Wang

et al. 2020

J of Medical Radiation Sci

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“…These patients are generally treated with surgery of the primary tumor and lymph nodes followed by radiotherapy plus/minus chemotherapy or with definitive radio-chemotherapy alone (2)(3)(4)(5)(6). These multimodal treatments are often associated with significant toxicities and functional restrictions (2)(3)(4)(5)(6)(7)(26)(27)(28). The most common acute toxicities that are related to radiotherapy and radio-chemotherapy include dermatitis and oral mucositis (2)(3)(4)(5).…”

Section: Discussionmentioning

confidence: 99%

“…If interruptions of the radiotherapy course are required or the concurrent chemotherapy cannot be administered with the complete planned dose, the patients' prognoses become worse (29,30). Xerostomia is a significant late morbidity that can be a consequence of surgical resection of one or both parotid glands and/or radio(chemo)therapy (2)(3)(4)(5)(6)(7)(26)(27)(28)(29)(30)(31). This type of late toxicity can significantly impair the patients' quality of life and lead to other late morbidities.…”

Section: Discussionmentioning

confidence: 99%

A New Phantom for Individual Verification of the Dose Distribution in Precision Radiotherapy for Head-and-Neck Cancer

et al. 2019

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Background/Aim: Many patients with head-andneck cancers receive radiotherapy. Treatment planning can be very complex in case of dental fillings or implants that cause metal artefacts. Verification of dose distributions may be performed using specific phantoms. This study aimed to develop a 3D-printed phantom that can be produced easily and cost-effectively. Patients and Methods: The phantom was designed to allow fast adaption to a patient's individual situation with a particular focus on metal artefacts due to dental fillings. Bone and soft-tissue shells were 3D-printed and filled with tissue-equivalent materials. Results: Attenuation properties of the tissue-equivalent structures in the phantom corresponded well to the structures of real human anatomy. In magnetic resonance (MR)-imaging, useful signals of the materials in the phantom were obtained. Conclusion: The phantom met the requirements including equivalence with human tissues and can be useful for highly individual treatment planning in precision-radiotherapy of head-and-neck cancers. It can be also used for scientific issues related to MR-imaging.

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“…Since the administration of an absorbent, self-adhesive dressing appeared a promising approach to reduce radiation dermatitis, we performed a randomized trial (RAREST-01) that compared the new dressing Mepitel® Film to standard skin care with respect to radiation dermatitis rates [7,8].…”

Section: Discussionmentioning

confidence: 99%

“…Grade ≥2 dermatitis and grade ≥2 mucositis rates were very high in previous studies (86-92% and 86-100%, respectively) and require improvement [4][5][6]. In the previous RAREST-01 trial that compared the dressing Mepitel® Film to standard skin care in patients irradiated for head-and-neck cancer, dermatitis rates were lower than expected in both groups [7,8].…”

Section: Introduction Background and Rationale {6a}mentioning

confidence: 88%

Radiotherapy related skin toxicity (RAREST-02): A reminder app developed to reduce radiation dermatitis in patients with head-and-neck cancer

Rades¹,

Narvaez²,

Dömer³

et al. 2019

Preprint

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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.

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A randomized trial (RAREST-01) comparing Mepitel® Film and standard care for prevention of radiation dermatitis in patients irradiated for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN)

Cited by 29 publications

References 23 publications

Mepitel Film is superior to Biafine cream in managing acute radiation‐induced skin reactions in head and neck cancer patients: a randomised intra‐patient controlled clinical trial

Mepitel Film is superior to Biafine cream in managing acute radiation‐induced skin reactions in head and neck cancer patients: a randomised intra‐patient controlled clinical trial

A New Phantom for Individual Verification of the Dose Distribution in Precision Radiotherapy for Head-and-Neck Cancer

Radiotherapy related skin toxicity (RAREST-02): A reminder app developed to reduce radiation dermatitis in patients with head-and-neck cancer

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