Ignite Creation Date:
2024-05-05 @ 10:26 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01102621
Status:
COMPLETED
Last Update Posted:
2010-04-13
First Post:
2010-04-06
Brief Title:
Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy
Sponsor:
Hospital AC Camargo
Organization:
Hospital AC Camargo
Study Overview
Official Title:
Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis Treatment for head and neck tumors often involve methods that affect the auditory system and cause hearing loss Neck dissection negatively impacts the lymphatic drainage chemotherapy uses ototoxic drugs radiotherapy affects blood flow and tissue radiation is toxic to the ear and may lead to hearing losses of various types and degrees
Objective To investigate occurrences of hearing loss and complaints among patients with head and neck tumors who underwent radiotherapy
Study design Prospective case-control study Setting Tertiary care center hospital
Subjects and Methods 282 subjects were evaluated 141 with head and neck tumors and 141 as an age-matched control group The controls had never undergone oncological treatment that put their hearing at risk All subjects underwent audiological evaluation including the HHIE questionnaire pure tone audiometry speech audiometry and immittance audiometry The radiation dose received by the auditory system was calculated based on the percentage of the external auditory canal included in the radiation field
Objective To investigate occurrences of hearing loss and complaints among patients with head and neck tumors who underwent radiotherapy
Study design Prospective case-control study Setting Tertiary care center hospital
Subjects and Methods 282 subjects were evaluated 141 with head and neck tumors and 141 as an age-matched control group The controls had never undergone oncological treatment that put their hearing at risk All subjects underwent audiological evaluation including the HHIE questionnaire pure tone audiometry speech audiometry and immittance audiometry The radiation dose received by the auditory system was calculated based on the percentage of the external auditory canal included in the radiation field
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None