Hearing LossNCT01102621
Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy
An observational study of Hearing Loss, run by Hospital A.C. Camargo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 11 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- How many people
- 282 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2005to Jul 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 84 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study design: Prospective, case-control study. Setting: Tertiary care center hospital.
Who may be able to join
- 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.
Who cannot join
- congenital hearing loss
- otological surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Medical subject headings
- Hearing Loss, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: patientes were evaluated two years after finished the treatement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startJan 2005
- Primary completionJan 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital A.C. Camargo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102621
- Sponsor's protocol ID
- HL1
- Status last verified
- Mar 2010
- First submitted
- 6 Apr 2010
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21079158
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy
- ClinicalTrials.gov ID
- NCT01102621
- Acronym / sponsor ID
- HL1
- Conditions
- Hearing Loss
- Keywords
- hearing loss, head and neck cancer, radiotherapy, hearing complaint, Hearing loss due to the exposure of radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Hospital A.C. CamargoUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 11 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study design: Prospective, case-control study. Setting: Tertiary care center hospital.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- congenital hearing loss
- otological surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
- Derived from this study: PubMed 21079158Schultz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Hospital A.C. Camargo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01102621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2010.