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

Krankenhaus Barmherzige Schwestern Linz30 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Head and Neck Cancer Radiotherapy

Interventions

OCTDEVICE

3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck

DermatoscopeDEVICE

2x2 pictures taken with a dermatoscope

3-Colour FISHGENETIC

Blood sample is examined for breaks per metaphase to determine radiation sensibility of the individual

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Upper Austria, Austria

Outcomes

Primary Outcomes

early radiation induced skin structure changes detected in OCT

any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

Time frame: First week of radiation therapy

Secondary Outcomes

detection of any skin strucure changes with OCT during the course of RT

any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

Time frame: weeks 1 - 6 of radiation therapy

Correlation of OCT changes with clinical appearent acute side effetcs

Correlation of OCT changes with CTC radiation toxicity

Time frame: weeks 1 - 6 of radiation therapy

Correlation of OCT changes with clinical appearent late side effetcs

Correlation of OCT changes with CTC radiation toxicity

Time frame: 1 year post-RT

Correlation of OCT changes with radiation sensitivity

Correlation of OCT with chromosome-breaks per metaphasis in in-vitro irradiated blood lymphocytes (FISH)

Time frame: OCT: weeks 1-6 of radiation therapy; FISH: pre-RT

Correlation of OCT changes with dermatoscopic skin appearance

Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy

Time frame: weeks 1-6 of RT

Correlation of quality of live with OCT and radiation sensitivity

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

Data from ClinicalTrials.gov

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