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Radiotherapy associated pores and skin toxicity (RAREST-01): Mepitel® movie versus customary care in sufferers with regionally superior head-and-neck most cancers.
BMC Most cancers. 2018 Feb 17;18(1):197
Authors: Narvaez C, Doemer C, Idel C, Setter C, Olbrich D, Ujmajuridze Z, Carl JH, Rades D
Summary
BACKGROUND: The intention of the current trial is to analyze a brand new choice of pores and skin safety with the intention to scale back the speed of grade???2 pores and skin toxicity in sufferers receiving radiotherapy alone or radiochemotherapy for regionally superior squamous cell carcinoma of the head-and-neck (SCCHN).
METHODS / DESIGN: This can be a randomized, active-controlled, parallel-group multi-center trial that compares the next remedies of radiation dermatitis in sufferers with head-and-neck most cancers: Mepitel® Movie (Arm A) vs. customary care (Arm B). The first intention of this trial is to analyze the speed of sufferers experiencing grade???2 radiation dermatitis (in keeping with Widespread Toxicity Standards for Adversarial Occasions (CTCAE) Model four.03) till 50 Gy of radiotherapy. Analysis till 50 Gy of radiotherapy has been chosen as the first endpoint, since as much as 50 Gy, the irradiated quantity contains the first tumor and the bilateral cervical and supraclavicular lymph nodes, and, due to this fact, is comparable in all sufferers. After 50 Gy, irradiated volumes are very particular person, relying on location and dimension of the first tumor, involvement of lymph nodes, and the remedy method (definitive vs. adjuvant). As well as, the next endpoints might be evaluated: Time to grade 2 radiation dermatitis till 50 Gy of radiotherapy, charge of sufferers experiencing grade???2 radiation dermatitis throughout radio(chemo)remedy, charge of sufferers experiencing grade???three pores and skin toxicity throughout radio(chemo)remedy, opposed occasions, high quality of life, and dermatitis-related ache. Administration of Mepitel® Movie might be thought of to be clinically related, if the speed of grade???2 radiation dermatitis might be diminished from 85% to 65%.
DISCUSSION: If administration of Mepitel® Movie as a substitute of normal care will have the ability to considerably scale back the speed of grade???2 radiation dermatitis, it may develop into the brand new customary of skincare in sufferers irradiated for SCCHN.
TRIAL REGISTRATION: clinicaltrials.gov NCT03047174 . Registered on 26th of January, 2017. First affected person included on ninth of Could, 2017.
PMID: 29454311 [PubMed – in process]