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

Krankenhaus Barmherzige Schwestern Linz

Status: Completed

Conditions: Radiotherapy; Head and Neck Cancer

Treatments: Device: OCT; Genetic: 3-Colour FISH; Device: Dermatoscope

Study type: Observational

Funder types: Other

Identifiers

NCT04610645

EKS 39/18

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Head and Neck Cancer Patients

Description:

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

Treatment:

Device: Dermatoscope

Genetic: 3-Colour FISH

Device: OCT