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

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.

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Key information

Conditions

Hearing Loss Ear Diseases Head and Neck Neoplasms Hearing Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

11 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital A C Camargo

São Paulo, 01509-900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
radiotherapy alone or in combination, in which the auditory system was included in the field of irradiation.
The group of non-exposed individuals (control group)
had to be patients who had not undergone oncological treatment that put their hearing at risk
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.

Exclusion criteria

congenital hearing loss
otological surgery

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospital A.C. Camargo

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Apr 13, 2010
Registry last updated: Apr 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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