Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy
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|ClinicalTrials.gov Identifier: NCT01102621|
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : April 13, 2010
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||282 participants|
|Observational Model:||Case Control|
|Official Title:||Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||July 2007|
case-control, head and neck cancer with radiotherapy
The group of exposed individuals had to be patients with disease-free survival interval of at least two years subsequent to treatment for head and neck cancer by means of radiotherapy alone or in combination, in which the auditory system was included in the field of irradiation.
case-control, head an neck cancer without radiotherapy
The group of non-exposed individuals (control group) had to be patients who had not undergone oncological treatment that put their hearing at risk and who were age-matched (2 years). This group was formed by individuals who had had pelvic tumors or skin tumors and who had only undergone local surgery to remove their tumors, and by female volunteers from the hospital. All of these individuals were asked whether they would be willing to participate in a study, without knowing in advance whether they had any previous hearing problems or complaints.
- The hearing loss was evaluated through conventional tone threshold audiometry and a questionaire of hearing handicap was applied to both groups (individuals exposed to radiotherapy and the control group). [ Time Frame: patientes were evaluated two years after finished the treatement ]We observed mild to moderate hearing losses at frequencies of 57.4% in right ears and 59.6% in left ears in the group exposed to radiotherapy and in the control group, 43.3% ofmild to moderate hearing loss in both ears.Severe or profound hearing losses or anacusis occurred at frequencies of 6.4% in right ears and 8.5% in left ears, versus only 1.4% in the control group.Furthermore, severe handicap was observed in 2.8% of the individuals in the control group, versus 19.1% in the group exposed to radiotherapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102621
|Hospital A C Camargo|
|São Paulo, SP, Brazil, 01509-900|