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

This study has been completed.
Sponsor:
Information provided by:
Hospital A.C. Camargo
ClinicalTrials.gov Identifier:
NCT01102621
First received: April 6, 2010
Last updated: April 12, 2010
Last verified: March 2010
  Purpose

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
Hearing Loss

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy

Resource links provided by NLM:


Further study details as provided by Hospital A.C. Camargo:

Primary Outcome Measures:
  • 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.


Enrollment: 282
Study Start Date: January 2005
Study Completion Date: July 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   11 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102621

Locations
Brazil
Hospital A C Camargo
São Paulo, SP, Brazil, 01509-900
Sponsors and Collaborators
Hospital A.C. Camargo
  More Information

No publications provided by Hospital A.C. Camargo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hearing loss and Complaint in patients with head and neck cancer treated with radiotherapy, Hospital A C Camargo
ClinicalTrials.gov Identifier: NCT01102621     History of Changes
Other Study ID Numbers: HL1
Study First Received: April 6, 2010
Last Updated: April 12, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital A.C. Camargo:
hearing loss
head and neck cancer
radiotherapy
hearing complaint
Hearing loss due to the exposure of radiotherapy

Additional relevant MeSH terms:
Hearing Loss
Deafness
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014