Pilot study evaluating changes in the oral mucosa using optical coherence tomography as part of radio(chemo)therapy in patients with head and neck cancer

• Conditions: C04; C10; Malignant neoplasm of floor of mouth; Malignant neoplasm of oropharynx

• Registration Number: DRKS00015229
• Lead Sponsor: niversitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Brief Summary

Due to the COVID-19 pandemic, recruitment was initially interrupted and then not reactivated due to a lack of recruitment. An evaluation was not possible due to insufficient patient numbers.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-13
• Study Completion: 2022-11-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Age =18 years; good general condition according to WHO grade 0-1; patients with oropharyngeal carcinoma + oral cavity; primary / postoperative radiotherapy or chemoradiotherapy with cisplatin +/- 5-FU; with a total oral dose of =40 Gy; prescribed total dose (GD) in primary radiotherapy (RTx) / chemoradiotherapy (RCTx) = 70 Gy; prescribed GD at adjuvant RTx / RTCx = 60 Gy; adequate mouth opening; Trism = grade I; preserved anterior teeth after dental restoration (fixed implants or bridges are permitted); signed declaration of consent

Exclusion Criteria

Pre-irradiation with significant load (> 10 Gy) of the oral cavity; expected lack of compliance; missing anterior teeth/removable prosthesis for anterior teeth; Trismus > Grade I (restricted mouth opening); participation in an intervention study with drug application or modification of the radio(chemo)therapy regimen 4 weeks before or during radiotherapy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of oral mucosa evaluation and epithelial layer thickness determination using OCT and correlation of changes in epithelial thickness with clinical severity of oral mucositis.

Secondary Outcome Measures

Name	Time	Method
- Decrease and increase of epithelial layer thickness over time<br>- Correlation of the epithelial layer thickness changes with applied Dose in this mucosal region<br>- Incidence of mucositis grade 2 and 3<br>- Time to manifestation of mucositis grade 2 and 3 according to EORTC/RTOG scoring system