Clinical trial NCT04610645: Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer
Official title: Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Radiotherapy
Keywords: Optical coherence tomography
OCT
Head and neck cancer
radiotherapy
radiation therapy
skin toxicity
radiation sensitivity
FISH
Quality of Life
EORTC QLQ C30
EORTC H&N 43
Radiochemotherapy
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
Collaborators: name: Verein zur Forschungsförderung der Krebshilfe OÖ
name: RECENDT GmbH
name: Johannes Kepler Universität Linz, Abteilung FLLL
name: Universitätsklinikum Erlangen
name: Andreas Fahl Medizintechnik-Vertrieb GmbH
First posted: 2020-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutively treated patients with head and neck cancer at the department of radiation therapy Ordensklinikum Linz Barmherzige Schwestern

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).

Eligibility criteria: 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

Primary outcomes:
measure: early radiation induced skin structure changes detected in OCT
timeFrame: First week of radiation therapy
Secondary outcomes:
measure: detection of any skin strucure changes with OCT during the course of RT
timeFrame: weeks 1 - 6 of radiation therapy
measure: Correlation of OCT changes with clinical appearent acute side effetcs
timeFrame: weeks 1 - 6 of radiation therapy
measure: Correlation of OCT changes with clinical appearent late side effetcs
timeFrame: 1 year post-RT
measure: Correlation of OCT changes with radiation sensitivity
timeFrame: OCT: weeks 1-6 of radiation therapy; FISH: pre-RT
measure: Correlation of OCT changes with dermatoscopic skin appearance
timeFrame: weeks 1-6 of RT
measure: Correlation of quality of live with OCT and radiation sensitivity
timeFrame: weeks 1-6 of RT, 6 weeks and 1 year post-RT
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern
state: Upper Austria
Study officials:
affiliation: Ordensklinikum Linz GmbH Barmherzige Schwestern (Dept. Radiooncology)
name: Hans Geinitz, Prim. Univ.-Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: