Multicenter Randomized Double-Blind, Placebo-Controlled Trial GORTEC (Groupe Oncologie Radiotherapie Tete et Cou) 2009-01 Evaluating the Effect of the Regenerating Agent on Radiodermatitis of Head and Neck Cancer Patients

Tao, Yungan; Aupérin, Anne; Siré, C.; Martin, Michel; Saliou, Marie; Bardet, É.; Sun, Xu; Chatellier, Thierry; Morand, Clotilde; Cornely, A.; Angokai, M.; Rito, Alessia Di; Kichenin, Ketty; Blanchard, Pierre; D’Onofrio, Ida; Bourhis, Jean

doi:10.1016/j.ijrobp.2017.07.019

Cited by 13 publications

(8 citation statements)

References 20 publications

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“…Radiation-induced dermatitis is a common and serious side effect in patients with breast cancer or head and neck cancer who receive radiotherapy 31,32 ; however, there is currently no effective treatment, thus remaining a significant clinical concern that further negatively affects the patient's quality of life. 3,33 Towards promoting research into the pathophysiology of this response, we successfully established radiation-induced acute and chronic dermatitis rat models using 90 Gy of radiation exposure to the skin.…”

Section: Discussionmentioning

confidence: 99%

Establishment and characterization of a radiation‐induced dermatitis rat model

Sheng

Zhou

Wang

et al. 2019

J Cellular Molecular Medi

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Radiation‐induced dermatitis is a common and serious side effect after radiotherapy. Current clinical treatments cannot efficiently or fully prevent the occurrence of post‐irradiation dermatitis, which remains a significant clinical problem. Resolving this challenge requires gaining a better understanding of the precise pathophysiology, which in turn requires establishment of a suitable animal model that mimics the clinical condition, and can also be used to investigate the mechanism and explore effective treatment options. In this study, a single dose of 90 Gy irradiation to rats resulted in ulceration, dermal thickening, inflammation, hair follicle loss, and sebaceous glands loss, indicating successful establishment of the model. Few hair follicle cells migrated to form epidermal cells, and both the severity of skin fibrosis and hydroxyproline levels increased with time post‐irradiation. Radiation damaged the mitochondria and induced both apoptosis and autophagy of the skin cells. Therefore, irradiation of 90 Gy can be used to successfully establish a rat model of radiation‐induced dermatitis. This model will be helpful for developing new treatments and gaining a better understanding of the pathological mechanism of radiation‐induced dermatitis. Specifically, our results suggest autophagy regulation as a potentially effective therapeutic target.

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Section: Discussionmentioning

confidence: 99%

Establishment and characterization of a radiation‐induced dermatitis rat model

Sheng

Zhou

Wang

et al. 2019

J Cellular Molecular Medi

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“…In the trial by Tao et al, 73% of the HNC patients developed moist desquamation after RT (total dose 70 Gy) combined with Cetuximab. Skincare consisted of a regenerating agent, which is an alternative wound healing approach using innovative-engineered biopolymers [29]. Chan et al demonstrated in a single-blind, randomised controlled trial comparing a silicone-based film forming gel dressing versus 10% Glycerine (Sorbolene cream), that 41% in the dressing group and 49% in the cream group developed grade 3 ARD.…”

Section: Discussionmentioning

confidence: 99%

Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial)

Robijns

Lodewijckx

Bollen

et al. 2021

Radiotherapy and Oncology

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Background and purpose: The purpose of this study was to investigate the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) in head and neck cancer (HNC) patients. Materials and methods: A randomised, placebo-controlled trial (RCT) with 46 HNC patients who underwent radiotherapy (RT) with or without concomitant chemotherapy was set up (DERMISHEAD trial). Patients were randomised to receive PBM or placebo treatments from the first day of RT (2Â/week) alongside the institutional skincare. The severity of skin reactions was assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v4.03) and the Radiotherapy-Induced Skin Reaction Assessment Scale (RISRAS). Quality of life (QoL) was evaluated using the Skindex-16 questionnaire. Results: PBMT significantly reduced NCI-CTCAE grade 2-3 ARD with 49% at the end of RT. Conclusion:The results of the first RCT in HNC patients showed that PBMT is an effective method to prevent the development of severe ARD. These results support the implementation of PBM in the clinical oncology -radiotherapy practice.

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“… 1 , 2 RD affects especially head and neck cancer patients where the skin is part of the target volume. 3 , 4 …”

Section: Introductionmentioning

confidence: 99%

“…1,2 RD affects especially head and neck cancer patients where the skin is part of the target volume. 3,4 RD can cause pain, pruritus, burning, and discomfort, thus affecting the quality of life of a patient. 5 Acute injury occurs within hours after radiation exposure.…”

Section: Introductionmentioning

confidence: 99%

Chamomile Gel versus Urea Cream to Prevent Acute Radiation Dermatitis in Head and Neck Cancer Patients: Results from a Preliminary Clinical Trial

et al. 2020

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We assessed safety and potential efficacy of a chamomile gel compared with urea cream to prevent acute radiation dermatitis in head and neck cancer patients. We assessed safety and potential efficacy of the chamomile gel in escalating concentrations of 2.50%, 5.00% and 8.35% of chamomile. Concentration of 8.35% was chosen for a randomized trial comparing chamomile gel (8.35%) with urea cream (n = 24 per group), for potential efficacy to delay or prevent radiation dermatitis in these patients. Preliminary results demonstrate a delayed onset of dermatitis, with onset of Grade 2 dermatitis at 5.1 (1.3) weeks in the chamomile group and 4.5 (1.3) weeks in the urea group (effect size of 0.46). Itching, burning and hyperpigmentation were more frequently reported in the urea group. Results indicates a potential efficacy of the chamomile gel. Further studies are needed to confirm the effect of the chamomile gel in reducing or delaying the occurrence of radiation dermatitis.

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Multicenter Randomized Double-Blind, Placebo-Controlled Trial GORTEC (Groupe Oncologie Radiotherapie Tete et Cou) 2009-01 Evaluating the Effect of the Regenerating Agent on Radiodermatitis of Head and Neck Cancer Patients

Cited by 13 publications

References 20 publications

Establishment and characterization of a radiation‐induced dermatitis rat model

Establishment and characterization of a radiation‐induced dermatitis rat model

Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial)

Chamomile Gel versus Urea Cream to Prevent Acute Radiation Dermatitis in Head and Neck Cancer Patients: Results from a Preliminary Clinical Trial

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