Phase 3 Randomized Trial of Topical Steroid Versus Placebo for Prevention of Radiation Dermatitis in Patients With Head and Neck Cancer Receiving Chemoradiation

Yokota, Tomoya; Zenda, Sadamoto; Ota, Ichiro; Yamazaki, Tomoko; Yamaguchi, Takuhiro; Ogawa, Takenori; Tachibana, Hideki; Toshiyasu, Takashi; Homma, Akihiro; Miyaji, Tempei; Mashiko, Tomoe; Hamauchi, Satoshi; Tominaga, Kuniko; Ishii, Shinobu; Otani, Yui; Orito, N.; Uchitomi, Yosuke

doi:10.1016/j.ijrobp.2021.05.133

Cited by 17 publications

(12 citation statements)

References 27 publications

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“…The standard radiation dose of CRT for HNC is 70 Gy in 35 fractions (fr) for the definitive setting and 60 to 66 Gy in 30 to 33 fr for the postoperative setting. In a recent phase III clinical trial, Yokota et al (9) provide evidence that topical steroids have the potential to lessen the serious nature of radiation dermatitis and thereby become an important therapeutic tool in managing radiation dermatitis induced by high-dose irradiation with chemotherapy in the care of head and neck cancer (HNC).…”

Section: Topical Steroids and Non-steroid Agentsmentioning

confidence: 99%

Prophylaxis and Management of Radiation-Induced Dermatitis

Alzanbagi¹,

Alshaqaqiq²,

Alsadi³

et al. 2022

JOHS

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Radiation dermatitis is an acute skin reaction that occurs as a result of radiotherapy used to treat a range of different cancers. The severity of symptoms ranges from erythema to dry desquamation (dry, flaky skin with itching) to moist desquamation (serious exudate, edema, and blistering). While a variety of topical agents and dressings are used to ameliorate side effects, there is minimal evidence to support their use. This study aimed to review the evidence on radiation-induced dermatitis, its prophylaxis, and its management. Only a few studies have found that specific topical agents have a significant benefit. Film dressings are the most efficient means of preventing acute radiation dermatitis, whereas foam dressings were found to be beneficial in treating it. In a preventive situation, barrier films and silicone-based gel treatments may lower the severity of skin reactions and symptoms and entirely halt the onset of moist desquamation. Radiation dermatitis has been prevented and treated with a variety of topical and systemic medications, but there is not enough data to recommen

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Section: Topical Steroids and Non-steroid Agentsmentioning

confidence: 99%

Prophylaxis and Management of Radiation-Induced Dermatitis

Alzanbagi¹,

Alshaqaqiq²,

Alsadi³

et al. 2022

JOHS

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“…157 Topical cutaneous steroids do confer benefit for reducing radiation dermatitis in patients with head and neck cancer who are receiving chemoradiation, however. 158…”

Section: Head and Neck Oncologymentioning

confidence: 99%

“…While some studies have suggested a possible role for use of SCSs, a systematic review of this literature determined that no definitive conclusions could be reached based on the low quality of evidence 157 . Topical cutaneous steroids do confer benefit for reducing radiation dermatitis in patients with head and neck cancer who are receiving chemoradiation, however 158 …”

Section: Head and Neck Oncologymentioning

confidence: 99%

“…157 Topical cutaneous steroids do confer benefit for reducing radiation dermatitis in patients with head and neck cancer who are receiving chemoradiation, however. 158 Patients with head and neck cancer have increased risk of mortality from COVID-19. 159 The 30-day all-cause mortality rate from COVID-19 might be higher among patients with head and neck cancer than other cancers (19% vs 13%).…”

Section: Head and Neck Oncologymentioning

confidence: 99%

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Corticosteroid Use in Otolaryngology: Current Considerations During the COVID‐19 Era

Chang

McCoul

Briggs

et al. 2021

Otolaryngol.--head neck surg.

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Objective To offer pragmatic, evidence-informed advice on administering corticosteroids in otolaryngology during the coronavirus disease 2019 (COVID-19) pandemic, considering therapeutic efficacy, potential adverse effects, susceptibility to COVID-19, and potential effects on efficacy of vaccination against SARS-CoV-2, which causes COVID-19. Data Sources PubMed, Cochrane Library, EMBASE, CINAHL, and guideline databases. Review Methods Guideline search strategies, supplemented by database searches on sudden sensorineural hearing loss (SSNHL), idiopathic facial nerve paralysis (Bell’s palsy), sinonasal polyposis, laryngotracheal disorders, head and neck oncology, and pediatric otolaryngology, prioritizing systematic reviews, randomized controlled trials, and COVID-19–specific findings. Conclusions Systemic corticosteroids (SCSs) reduce long-term morbidity in individuals with SSNHL and Bell’s palsy, reduce acute laryngotracheal edema, and have benefit in perioperative management for some procedures. Topical or locally injected corticosteroids are preferable for most other otolaryngologic indications. SCSs have not shown long-term benefit for sinonasal disorders. SCSs are not a contraindication to vaccination with COVID-19 vaccines approved by the US Food and Drug Administration. The Centers for Disease Control and Prevention noted that these vaccines are safe for immunocompromised patients. Implications for Practice SCS use for SSNHL, Bell’s palsy, laryngotracheal edema, and perioperative care should follow prepandemic standards. Local or topical corticosteroids are preferable for most other otolaryngologic indications. Whether SCSs attenuate response to vaccination against COVID-19 or increase susceptibility to SARS-CoV-2 infection is unknown. Immunosuppression may lower vaccine efficacy, so immunocompromised patients should adhere to recommended infection control practices. COVID-19 vaccination with Pfizer-BioNTech, Moderna, or Johnson & Johnson vaccines is safe for immunocompromised patients.

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“…At present, about 95% of patients who receive radiation therapy will develop RD ( Rosenthal et al, 2019 ). Patients with breast cancer, head and neck cancer, lung cancer, or sarcoma are more likely to suffer from RD ( Fuzissaki et al, 2019 ; Tinkle et al, 2021 ; Yokota et al, 2021 ; Louie et al, 2022 ). Erythema is the predominant sign among RD patients, while 42 and 15% of patients developed RT-induced grade 3 and 4 skin toxicities characterized by desquamation, ulceration, and pigment changes ( Hu et al, 2018 ; Bontempo et al, 2021 ).…”

Section: Introductionmentioning

confidence: 99%

Prevention of Radiodermatitis With Topical Chinese Herbal Medicine: A Systematic Review and Meta-Analysis

Han

Cao

2022

Front. Pharmacol.

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Objectives: Topical Chinese herbal medicine (TCHM) is widely used to prevent radiodermatitis in patients who receive radiation therapy in China. However, evidence regarding its efficacy remains limited. The purpose of the review is to evaluate the effects of TCHM in preventing radiodermatitis.Methods: The protocol of this review was registered in PROSPERO (CRD42020220620). Relevant clinical trials were identified (from January 1, 2010, to April 24, 2022) through 11 electronic databases, including PubMed, SpringerLink, Proquest, the Cochrane Central Register of Controlled Trials, Scopus, the ProQuest Dissertation & Theses Global, PsycINFO, Applied Social Sciences Index and Abstracts, the Chinese National Knowledge Infrastructure Databases, Wangfang Data Knowledge Service Platform, and the Chongqing VIP Chinese Science and Technology Periodical Database. The quality of the included trials was assessed through a risk of bias assessment using Version 2 of the Cochrane risk-of-bias tool (RoB 2.0). We included RCTs that compared TCHM single used or as adjunctive treatment with routine drugs, conventional therapy, or placebo for cancer patients who are about to start radiation therapy and do not possess any type of dermatitis or skin lesions at that time. Primary outcomes of interest were the incidence of radiodermatitis and the grade of radiodermatitis according to the RTOG (Radiation Therapy Oncology Group). Secondary outcomes included the recovery time of skin and mucosa, the occurrence time of radiodermatitis, the radiation dose, quality of life, and adverse events. Data were summarized using risk ratio (RR) calculations and 95% confidence intervals (CI) for binary outcomes or mean difference (MD) with 95% CI for continuous outcomes. Certainty of the evidence was assessed according to the GRADE criteria.Results: In this review, 38 randomized controlled trials (RCTs) were included. Risk of bias assessment through RoB 2.0 showed that two studies were rated as low risk, two studies were rated as high risk, and the rest were rated as having some concerns. Compared with routine drugs, TCHM may have an advantage in reducing RTOG grading (RR = 0.46, 95%CI 0.35–0.60), decreasing the recovery time of radiodermatitis (MD = −2.35, 95%CI 3.58 to −1.12 days), delaying the occurrence of radiodermatitis (MD = 2.36, 95%CI 1.74–2.98), and improving the quality of life of patients (RR = 1.46, 95%CI 1.03–2.06). Compared with conventional therapy, TCHM may also have an advantage in decreasing the grade of RTOG (RR = 0.28, 95%CI 0.21–0.38).Conclusion: Current low evidence revealed that TCHM may have better efficacy in the prevention of radiodermatitis; however, more high-quality RCTs are still warranted to testify this conclusion.Systematic Review Registration: (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020220620), identifier (PROSPERO 2020 CRD42020220620).

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Phase 3 Randomized Trial of Topical Steroid Versus Placebo for Prevention of Radiation Dermatitis in Patients With Head and Neck Cancer Receiving Chemoradiation

Abstract: Phase 3 randomized trial of topical steroid versus placebo for prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiation,

Cited by 17 publications

References 27 publications

Prophylaxis and Management of Radiation-Induced Dermatitis

Prophylaxis and Management of Radiation-Induced Dermatitis

Corticosteroid Use in Otolaryngology: Current Considerations During the COVID‐19 Era

Prevention of Radiodermatitis With Topical Chinese Herbal Medicine: A Systematic Review and Meta-Analysis

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