Using optical coherence tomography to detect skin damage in head and neck cancer patients undergoing radiotherapy
Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients
This study is trying to see if a special imaging technique can spot early skin damage in head and neck cancer patients receiving radiation therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Krankenhaus Barmherzige Schwestern Linz Academic / other |
| Drugs / interventions | Cetuximab, chemotherapy, radiation |
| Locations | 1 site (Linz, Upper Austria) |
| Trial ID | NCT04610645 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess whether skin damage caused by radiation therapy in head and neck cancer patients can be detected at a subclinical level using optical coherence tomography (OCT). Patients will undergo OCT measurements before, during, and after their radiation therapy, alongside dermatoscopy evaluations and self-assessments of their quality of life. Additionally, a radiation sensitivity analysis will be performed on their peripheral blood lymphocytes prior to treatment. The study seeks to correlate OCT-detected skin damage with clinical toxicity experienced by patients.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with head and neck cancer who are scheduled to receive definitive or adjuvant radiation or radio-chemotherapy.
Not a fit: Patients with reduced mental capacity, those receiving specific treatments like C225 Cetuximab, or individuals with overt skin disease or extensive tattoos in the neck region may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to monitor and potentially mitigate skin damage in patients receiving radiotherapy for head and neck cancer.
How similar studies have performed: While the use of optical coherence tomography in this context is relatively novel, similar studies have shown promise in detecting subclinical changes in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Linz, Upper Austria
- Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern — Linz, Upper Austria, Austria (Recruiting)
Study contacts
- Principal investigator: Hans Geinitz, Prim. Univ.-Prof. Dr. — Ordensklinikum Linz GmbH Barmherzige Schwestern (Dept. Radiooncology)
- Study coordinator: Elisabeth Silberberger, MSc
- Email: elisabeth.silberberger@ordensklinikum.at
- Phone: +43 (732) 7677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.