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Trial Title:
Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)
NCT ID:
NCT05789316
Condition:
Head and Neck Cancer Survivors
Cancer of the Head and Neck Surviors
Conditions: Official terms:
Head and Neck Neoplasms
Ototoxicity
Conditions: Keywords:
survivorship
quality of life
cisplatin
radiation
head and neck cancer
hearing loss
ototoxicity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Ototoxicity Screening Protocol
Description:
The ototoxicity screening protocol contains a functional and objective component. The
functional component is the Hearing Handicap Inventory for the Elderly - Screening
Version (HHIE-S). The objective component will be pure tone audiometry. A 2 kHz tone at
40 dB will play through over-the-ear headphones and subjects will indicate whether they
heard it.
Arm group label:
Ototoxicity Screening Protocol
Summary:
To evaluate the effectiveness, feasibility, acceptability, and appropriateness of an
ototoxicity screening protocol among head and neck (H&N) cancer patients followed in
survivorship clinic that received cisplatin-based chemoradiation therapy (CRT).
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Lee, M.D.
Phone:
314-935-5000
Email:
david.s.lee@wustl.edu
Investigator:
Last name:
David Lee, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Kate McClannahan, AuD, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Sidharth Puram, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Melissa Portell, PA-C
Email:
Sub-Investigator
Investigator:
Last name:
Cathryn Collopy, AuD
Email:
Sub-Investigator
Investigator:
Last name:
Emma Travis
Email:
Sub-Investigator
Investigator:
Last name:
Susan Wong
Email:
Sub-Investigator
Start date:
June 6, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Agency class:
Other
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789316
http://www.siteman.wustl.edu
