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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-08

Study Completion Date

2025-04-08

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Head and Neck Cancer Radiotherapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Head and Neck Cancer Patients

Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer

OCT

Intervention Type DEVICE

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

Dermatoscope

Intervention Type DEVICE

2x2 pictures taken with a dermatoscope

3-Colour FISH

Intervention Type GENETIC

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

Interventions

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OCT

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

Intervention Type DEVICE

Dermatoscope

2x2 pictures taken with a dermatoscope

Intervention Type DEVICE

3-Colour FISH

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

Intervention Type GENETIC

Other Intervention Names

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Lumedica OQlabscope 2.0 Heine iC1 Set/6 Fluorescent In Situ Hybridisation

Eligibility Criteria

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Inclusion Criteria

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