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

April 6, 2010
April 12, 2010
January 2005
January 2007   (final data collection date for primary outcome 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). [ 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.
Same as current
Complete list of historical versions of study NCT01102621 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Hearing Loss
Not Provided
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
282
July 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
11 Years to 84 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01102621
HL1
No
Hearing loss and Complaint in patients with head and neck cancer treated with radiotherapy, Hospital A C Camargo
Hospital A.C. Camargo
Not Provided
Not Provided
Hospital A.C. Camargo
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP