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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Held, Thomas Herpel, Christopher Schwindling, Franz Sebastian Christ, Leo Lang, Kristin Regnery, Sebastian Eichkorn, Tanja Hommertgen, Adriane Jaekel, Cornelia Krisam, Johannes Moratin, Julius Mrosek, Jan Metzger, Karl Zaoui, Karim Moutsis, Tracy Harrabi, Semi Herfarth, Klaus Freudlsperger, Christian Rammelsberg, Peter Debus, Jürgen Adeberg, Sebastian |
| Abstract | Background Despite modern treatment techniques, radiotherapy (RT) in patients with head and neck cancer (HNC) may be associated with high rates of acute and late treatment-related toxicity. The most effective approach to reduce sequelae after RT is to avoid as best as possible healthy tissues and organs at risk from the radiation target volume. Even small geometric changes can lead to a significant dose reduction in normal tissue and better treatment tolerability. The major objective of the current study is to investigate 3D printed, tooth-borne tissue retraction devices (TRDs) compared to conventional dental splints for head and neck RT. Methods In the current two-arm randomized controlled phase II trial, a maximum of 34 patients with HNC will be enrolled. Patients will receive either TRDs or conventional dental splints (randomization ratio 1:1) for the RT. The definition of the target volume, modality, total dose, fractionation, and imaging guidance is not study-specific. The primary endpoint of the study is the rate of acute radiation-induced oral mucositis after RT. The quality of life, local control and overall survival 12 months after RT are the secondary endpoints. Also, patient-reported outcomes and dental status, as well as RT plan comparisons and robustness analyzes, will be assessed as exploratory endpoints. Finally, mesenchymal stem cells, derived from the patients’ gingiva, will be tested in vitro for regenerative and radioprotective properties. Discussion The preliminary clinical application of TRD showed a high potential for reducing acute and late toxicity of RT in patients with HNC. The current randomized study is the first to prospectively investigate the clinical tolerability and efficacy of TRDs for radiation treatment of head and neck tumors. Trial registration: ClinicalTrials.gov; NCT04454697; July 1st 2020; https://clinicaltrials.gov/ct2/show/record/NCT04454697 . |
| Related Links | https://ro-journal.biomedcentral.com/counter/pdf/10.1186/s13014-021-01803-8.pdf |
| Ending Page | 8 |
| Page Count | 8 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| DOI | 10.1186/s13014-021-01803-8 |
| Journal | Radiation Oncology |
| Issue Number | 1 |
| Volume Number | 16 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2021-04-17 |
| Access Restriction | Open |
| Subject Keyword | Cancer Research Oncology Radiotherapy Imaging Radiology Intensity-modulated radiotherapy Particle therapy Toxicity Radiation-induced oral mucositis Xerostomia Squamous cell carcinoma Salivary gland tumor |
| Content Type | Text |
| Resource Type | Article |
| Subject | Radiology, Nuclear Medicine and Imaging Oncology |
| Journal Impact Factor | 3.3/2023 |
| 5-Year Journal Impact Factor | 3.6/2023 |
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