Radiotherapy related skin toxicity (RAREST-01): Mepitel® film versus standard care in patients with locally advanced head-and-neck cancer

Abstract

BackgroundThe aim of the present trial is to investigate a new option of skin protection in order to reduce the rate of grade ≥ 2 skin toxicity in patients receiving radiotherapy alone or radiochemotherapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).Methods / DesignThis is a randomized, active-controlled, parallel-group multi-center trial that compares the following treatments of radiation dermatitis in patients with head-and-neck cancer: Mepitel® Film (Arm A) vs. standard care (Arm B). The primary aim of this trial is to investigate the rate of patients experiencing grade ≥ 2 radiation dermatitis (according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03) until 50 Gy of radiotherapy. Evaluation until 50 Gy of radiotherapy has been selected as the primary endpoint, since up to 50 Gy, the irradiated volume includes the primary tumor and the bilateral cervical and supraclavicular lymph nodes, and, therefore, is similar in all patients. After 50 Gy, irradiated volumes are very individual, depending on location and size of the primary tumor, involvement of lymph nodes, and the treatment approach (definitive vs. adjuvant). In addition, the following endpoints will be evaluated: Time to grade 2 radiation dermatitis until 50 Gy of radiotherapy, rate of patients experiencing grade ≥ 2 radiation dermatitis during radio(chemo)therapy, rate of patients experiencing grade ≥ 3 skin toxicity during radio(chemo)therapy, adverse events, quality of life, and dermatitis-related pain. Administration of Mepitel® Film will be considered to be clinically relevant, if the rate of grade ≥ 2 radiation dermatitis can be reduced from 85% to 65%.DiscussionIf administration of Mepitel® Film instead of standard care will be able to significantly reduce the rate of grade ≥ 2 radiation dermatitis, it could become the new standard of skin care in patients irradiated for SCCHN.Trial registrationclinicaltrials.gov NCT03047174. Registered on 26th of January, 2017. First patient included on 9th of May, 2017.

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

“…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].…”

“…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].…”

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

“…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).…”

“…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.…”

What is new when it comes to acute and chronic radiation-induced dermatitis in head and neck cancer patients?

“…There is evidently a need to carry out tests confirming the effectiveness of individual intervention. In 2018 a randomized Radiotherapy Related Skin Toxicity (RAREST-01) study commenced [26]. It compares standard care and Mepitel Film (gentle, transparent, breathable dressings) in patients with locally advanced squamous-cell carcinoma of the head and neck receiving radiotherapy or radiochemotherapy [26].…”