Clinical trial NCT01102621: Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy
Official title: Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Keywords: hearing loss
head and neck cancer
radiotherapy
hearing complaint
Hearing loss due to the exposure of radiotherapy
Lead sponsor: Hospital A.C. Camargo
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 282
Sex: ALL
Minimum age (years): 11
Maximum age (years): 84
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study design: Prospective, case-control study. Setting: Tertiary care center hospital.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: patientes were evaluated two years after finished the treatement
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital A C Camargo
state: SP
Study officials:
References:
citation: Schultz C, Goffi-Gomez MV, Pecora Liberman PH, Pellizzon AC, Carvalho AL. Hearing loss and complaint in patients with head and neck cancer treated with radiotherapy. Arch Otolaryngol Head Neck Surg. 2010 Nov;136(11):1065-9. doi: 10.1001/archoto.2010.180.