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

NCT01102621 | Completed

• 1 other identifier: HL1
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

hearing loss; head and neck cancer; radiotherapy; hearing complaint; Hearing loss due to the exposure of radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  patientes were evaluated two years after finished the treatement

Study Arms (2)

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.

Eligibility Criteria

• Age: 11 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study design: Prospective, case-control study. Setting: Tertiary care center hospital.

You may qualify if:

• 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.

You may not qualify if:

• congenital hearing loss
• otological surgery

Sponsors & Collaborators

• Hospital A.C. Camargo: lead

Study Sites (1)

Hospital A C Camargo

São Paulo, São Paulo, 01509-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 21079158 DERIVED

MeSH Terms

Conditions

Hearing Loss; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 13, 2010
• Study Start: January 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 13, 2010

Record last verified: 2010-03

Locations

BR (1)