scholarly journals Double-blind placebo-controlled multicenter phase II trial to evaluate D-methionine in preventing/reducing oral mucositis induced by radiation and chemotherapy for head and neck cancer

Head & Neck ◽  
2018 ◽  
Vol 40 (7) ◽  
pp. 1375-1388 ◽  
Author(s):  
Daniel A. Hamstra ◽  
Kuei C. Lee ◽  
Avraham Eisbruch ◽  
Prasad Sunkara ◽  
Sudhir Borgonha ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Phase Ii ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
Phase Ii Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Multicenter Phase

scholarly journals Efficacy and safety of Dentoxol® in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial

2020 ◽  
Vol 28 (12) ◽  
pp. 5871-5879
Author(s):  
Rajesh V. Lalla ◽  
Sebastián Solé ◽  
Sergio Becerra ◽  
Claudia Carvajal ◽  
Piero Bettoli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Phase Ii ◽  
Neck Cancer ◽  
Oral Mucositis ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Purpose The aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer. Methods A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed. Results The incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events. Conclusion The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.

scholarly journals Correction: Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus–unrelated Head and Neck Cancer: A Multicenter, Phase II Trial

2021 ◽  
Vol 27 (1) ◽  
pp. 357-357
Author(s):  
Ravindra Uppaluri ◽  
Katie M. Campbell ◽  
Ann Marie Egloff ◽  
Paul Zolkind ◽  
Zachary L. Skidmore ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Human Papillomavirus ◽  
Head And Neck ◽  
Phase Ii ◽  
Neck Cancer ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Multicenter Phase

scholarly journals Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus–Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial

2020 ◽  
Vol 26 (19) ◽  
pp. 5140-5152 ◽  
Author(s):  
Ravindra Uppaluri ◽  
Katie M. Campbell ◽  
Ann Marie Egloff ◽  
Paul Zolkind ◽  
Zachary L. Skidmore ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Human Papillomavirus ◽  
Head And Neck ◽  
Phase Ii ◽  
Neck Cancer ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Multicenter Phase

A randomized, double-blind, placebo controlled, phase II study to evaluate the efficacy of ginseng in reducing fatigue in patients treated for head and neck cancer

2020 ◽  
Vol 146 (10) ◽  
pp. 2479-2487
Author(s):  
Mauro Guglielmo ◽  
Patricia Di Pede ◽  
Salvatore Alfieri ◽  
Cristiana Bergamini ◽  
Francesca Platini ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Phase Ii ◽  
Neck Cancer ◽  
Phase Ii Study ◽  
Double Blind ◽  
Double Blind Placebo

Docetaxel plus cisplatin in recurrent and/or metastatic non-squamous-cell head and neck cancer: a multicenter phase II trial

2021 ◽  
Vol 38 (11) ◽  
Author(s):  
Yoshinori Imamura ◽  
Kaoru Tanaka ◽  
Naomi Kiyota ◽  
Hidetoshi Hayashi ◽  
Ichiro Ota ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Phase Ii ◽  
Neck Cancer ◽  
Squamous Cell ◽  
Phase Ii Trial ◽  
Multicenter Phase
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