Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer

Recruiting

• Conditions: Head and Neck Cancer; Radiotherapy
• Interventions: Device: OCT; Device: Dermatoscope; Genetic: 3-Colour FISH

• Registration Number: NCT04610645
• Lead Sponsor: Krankenhaus Barmherzige Schwestern Linz

Brief Summary

The purpose of this study is to determine whether any eventual skin damage caused by radiation therapy can be detected and monitored at a subclinical level via optical coherence tomography (OCT). Another key question is whether subclinical OCT detected skin damage correlates with acute and late clinical toxicity.

Detailed Description

Head and neck cancer patients that meet the eligibility criteria and singned the informed consent will undergo OCT-measurements before, during and after the course of radiation therapy. At the same time-points the skin areas are evaluated with dermatoscopy and patients are asked to self-assess their quality of life (EORTC QLQ C30 and respective head and neck module H\&N 43). Before the onset of radiation therapy radiation sensitivity analysis will be performed with in-vitro irradion of peripheral blood lymphocytes (FISH).

Study Timeline

• Study Start: 2020-06-08
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-10-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07
• Primary Completion: 2026-12-08
• Study Completion: 2026-12-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with cancer located at: nasopharynx, oropharynx, hypopharynx, larynx, oral cavity and definitive or adjuvant radiation- or radio-chemotherapy

Exclusion Criteria

• reduced mental capacity
• treatment with C225 Cetuximab
• bearded patients
• overt skin disease
• vast tattoos in the neck region

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head and Neck Cancer Patients	OCT	Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer
Head and Neck Cancer Patients	3-Colour FISH	Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer
Head and Neck Cancer Patients	Dermatoscope	Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer

Primary Outcome Measures

Name	Time	Method
early radiation induced skin structure changes detected in OCT	First week of radiation therapy	any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

Secondary Outcome Measures

Name	Time	Method
detection of any skin strucure changes with OCT during the course of RT	weeks 1 - 6 of radiation therapy	any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)
Correlation of OCT changes with clinical appearent acute side effetcs	weeks 1 - 6 of radiation therapy	Correlation of OCT changes with CTC radiation toxicity
Correlation of OCT changes with dermatoscopic skin appearance	weeks 1-6 of RT	Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy
Correlation of OCT changes with clinical appearent late side effetcs	1 year post-RT	Correlation of OCT changes with CTC radiation toxicity
Correlation of quality of live with OCT and radiation sensitivity	weeks 1-6 of RT, 6 weeks and 1 year post-RT	Correlation of quality of live as measured with the EORT QLC C30 and Head and neck module H\&N 43 with OCT and radiation sensitivity
Correlation of OCT changes with radiation sensitivity	OCT: weeks 1-6 of radiation therapy; FISH: pre-RT	Correlation of OCT with chromosome-breaks per metaphasis in in-vitro irradiated blood lymphocytes (FISH)

Trial Locations

Locations (1)

Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern; 🇦🇹 Linz, Upper Austria, Austria