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

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 - OCT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00015229

Enrollment

Registered

2019-12-13

Start date

2019-12-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C04 C10

Interventions

Group 1: OCT will be used as a method to evaluate mucosal epithelial thickness and to detect changes in the course of therapy. Finally, these results will be placed in the context of clinical mucositi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Contacts

Public ContactAnnett Klöber

Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Studienambulanz

STR.Studien@uniklinikum-dresden.de0351-458-13390

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026