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Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy

NCT01102621 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 282

Last updated 2010-04-13

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Hospital A.C. Camargo

    lead OTHER

Eligibility

Min Age
11 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-01-31
Completion
2007-07-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01102621 on ClinicalTrials.gov