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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102621
• Other study ID #: HL1
• Status: Completed
• Phase: N/A
• First received: April 6, 2010
• Last updated: April 12, 2010
• Start date: January 2005
• Est. completion date: July 2007

Study information

• Verified date: March 2010
• Source: Hospital A.C. Camargo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: July 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 84 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deafness
• Head and Neck Neoplasms
• Hearing Loss

Locations

Country	Name	City	State
Brazil	Hospital A C Camargo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital A.C. Camargo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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