Screening for hearing loss in head and neck cancer survivors
Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol
NA · Washington University School of Medicine · NCT05789316
This study tests a new way to check for hearing loss in head and neck cancer survivors who have had certain treatments to see if it can help improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT05789316 on ClinicalTrials.gov |
What this trial studies
This study evaluates an ototoxicity screening protocol for head and neck cancer survivors who have undergone cisplatin-based chemoradiation therapy. It aims to assess the effectiveness, feasibility, acceptability, and appropriateness of this screening among patients in a survivorship clinic. By identifying potential hearing loss early, the study seeks to improve the quality of life for these patients. The intervention involves a systematic approach to screening for ototoxicity, which can be a side effect of their cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are adult head and neck cancer survivors who have received cisplatin-based chemoradiation therapy.
Not a fit: Patients who have been evaluated by an audiologist in the past 12 months, use hearing aids, or have cochlear implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this screening could lead to early detection and management of hearing loss, significantly enhancing the quality of life for head and neck cancer survivors.
How similar studies have performed: While there is ongoing research in the area of ototoxicity screening, this specific approach for head and neck cancer survivors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (≥ 18 years old) * H\&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation. Exclusion Criteria: * Patient has been evaluated by an audiologist within the past 12 months * Use of a hearing aid * Received a cochlear implant * Cannot complete simple forms in English
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: David Lee, M.D. — Washington University School of Medicine
- Study coordinator: David Lee, M.D.
- Email: david.s.lee@wustl.edu
- Phone: 314-935-5000
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.
Conditions: Head and Neck Cancer Survivors, Cancer of the Head and Neck Surviors, survivorship, quality of life, cisplatin, radiation, head and neck cancer, hearing loss