Head and Neck Cancer SurvivorsNCT05789316
Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)
A study testing Ototoxicity Screening Protocol in people with Head and Neck Cancer Survivors and Cancer of the Head and Neck Surviors, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To evaluate the effectiveness, feasibility, acceptability, and appropriateness of an ototoxicity screening protocol among head and neck (H\&N) cancer patients followed in survivorship clinic that received cisplatin-based chemoradiation therapy (CRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer Survivors, Cancer of the Head and Neck Surviors
- What is being tested?
- Ototoxicity Screening Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 21 Nov 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥ 18 years old)
- H\&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation.
Who cannot join
- Patient has been evaluated by an audiologist within the past 12 months
- Use of a hearing aid
- Received a cochlear implant
- Cannot complete simple forms in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol
To evaluate the effectiveness, feasibility, acceptability, and appropriateness of an ototoxicity screening protocol among head and neck (H\&N) cancer patients followed in survivorship clinic that received cisplatin-based chemoradiation therapy (CRT).
- Being tested
- Ototoxicity Screening Protocol
- Keywords
- survivorship, quality of life, cisplatin, radiation, head and neck cancer, hearing loss, ototoxicity
- Medical subject headings
- Head and Neck Neoplasms, Hearing Loss, Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ototoxicity Screening ProtocolOther
The ototoxicity screening protocol contains a functional and objective component. The functional component is the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S). The objective component will be pure tone audiometry. A 2 kHz tone at 40 dB will play through over-the-ear headphones and subjects will indicate whether they heard it.
| Study group | Role | What they receive |
|---|---|---|
| Ototoxicity Screening Protocol | Experimental | After enrollment, participants will complete a pre-screening survey. Before their survivorship clinic visit, participants will complete the ototoxicity screening protocol and implementation outcome surveys. During their visit, they will receive counseling on ototoxicity and referral to audiology. After their visit, they will complete the SESMQ and WU-QOLv4 surveys and undergo pure tone audiometry. Each participant will complete this protocol once. The investigators will follow each participant by chart review for at least six months to evaluate for audiologic follow-up. Receives: Other: Ototoxicity Screening Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants who complete audiologic follow-up
Measured: Through completion of follow-up (estimated to be 6 months)
Secondary outcomes (6)
Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure
-Contains 4 statements about the proposed intervention that are scored on a five-point Likert scale (1 indicates the participant "completely disagrees", 5 indicates "completely agrees"). A score greater than or equal to 4 will indicate the intervention is feasible.
Measured: Before survivorship clinic visit (Day 1)
Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure
-Contains 4 statements about the proposed intervention that are scored on a five-point Likert scale (1 indicates the participant "completely disagrees", 5 indicates "completely agrees"). A score greater than or equal to 4 will indicate the intervention is acceptable.
Measured: Before survivorship clinic visit (Day 1)
Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure
-Contains 4 statements about the proposed intervention that are scored on a five-point Likert scale (1 indicates the participant "completely disagrees", 5 indicates "completely agrees"). A score greater than or equal to 4 will indicate the intervention is appropriate.
Measured: Before survivorship clinic visit (Day 1)
Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ)
-This questionnaire contains 20 situations. Participants rate each situation according to their ability to hear in the given situation (hearing ability scale; SESMQH) and their confidence in managing the given situation (confidence scale; SESMQC). The score for each situation ranges from 0 (poor hearing/low confidence) to 10 (normal hearing/high confidence), totaling 200 points for each scale. The higher the score indicates less hearing loss to the participant.
Measured: After survivorship clinic visit (Day 1)
Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL)
-This questionnaire contains 16 items on morbidities associated with H\&N cancer treatment. Twelve items are graded on a 5-point Likert scale. One question lists treatment-related morbidities and ask participants to identify their top three most important issues. The last three questions evaluate global QoL. It is scored on a scale from 0 (worst) to 100 (best). However, UW-QOL does not include symptoms of ototoxicity. Therefore, the investigators will modify it to include tinnitus and hearing loss as additional 5-point Likert scale questions and morbidities in the rank order question.
Measured: After survivorship clinic visit (Day 1)
Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire
It has been validated for use in populations of cancer patients and cancer survivors. 5 questions are presented using a Likert scale from 0-2, with higher scores indicating a higher level of social support.
Measured: After survivorship clinic visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start6 Jun 2023
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Responsible party
- Sponsor
- Investigators
- David Lee, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789316
- Sponsor's protocol ID
- 202302038
- Status last verified
- Jan 2026
- First submitted
- 16 Mar 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol
- ClinicalTrials.gov ID
- NCT05789316
- Acronym / sponsor ID
- 202302038
- Keywords
- survivorship, quality of life, cisplatin, radiation, head and neck cancer, hearing loss, ototoxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 29 Mar 2023 (actual)
- 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.
To evaluate the effectiveness, feasibility, acceptability, and appropriateness of an ototoxicity screening protocol among head and neck (H\&N) cancer patients followed in survivorship clinic that received cisplatin-based chemoradiation therapy (CRT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ototoxicity Screening Protocol | Experimental | Other: Ototoxicity Screening ProtocolAfter enrollment, participants will complete a pre-screening survey. Before their survivorship clinic visit, participants will complete the ototoxicity screening protocol and implementation outcome surveys. During their visit, they will receive counseling on ototoxicity and referral to audiology. After their visit, they will complete the SESMQ and WU-QOLv4 surveys and undergo pure tone audiometry. Each participant will complete this protocol once. The investigators will follow each participant by chart review for at least six months to evaluate for audiologic follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (≥ 18 years old)
- H\&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation.
Key exclusion criteria (4 listed)
- Patient has been evaluated by an audiologist within the past 12 months
- Use of a hearing aid
- Received a cochlear implant
- Cannot complete simple forms in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ototoxicity Screening ProtocolThe ototoxicity screening protocol contains a functional and objective component. The functional component is the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S). The objective component will be pure tone audiometry. A 2 kHz tone at 40 dB will play through over-the-ear headphones and subjects will indicate whether they heard it. | Other | Ototoxicity Screening Protocol |
Primary outcome
Rate of participants who complete audiologic follow-up
Time frame: Through completion of follow-up (estimated to be 6 months)
6 secondary outcomes
Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure
Time frame: Before survivorship clinic visit (Day 1)
Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure
Time frame: Before survivorship clinic visit (Day 1)
Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure
Time frame: Before survivorship clinic visit (Day 1)
Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ)
Time frame: After survivorship clinic visit (Day 1)
Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: After survivorship clinic visit (Day 1)
Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire
Time frame: After survivorship clinic visit (Day 1)
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 12 Jan 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer Survivors
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Active, not recruiting
Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors
Cancer Survivor, Dysphagia
Active, not recruiting
Cough, Expiratory Training, and Chronic Aspiration After Head and Neck Radiotherapy
Head and Neck Cancer
Not yet recruitingPhase 2
A Ph2, Colchicine For Inflammatory Carotid Injury And Disease Evolution After Radiotherapy
Head and Neck Cancer
Not yet recruiting
Speed of Processing Training to Improve Cognitive Functioning and Driving Performance in Head and Neck Cancer Survivors
Head and Neck Cancer (H&N)
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.
David Lee, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ototoxicity Screening Protocol in people with Head and Neck Cancer Survivors and Cancer of the Head and Neck Surviors, run by Washington University School of Medicine at 1 site in United States.
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 2 inclusion and 4 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 12 Jan 2026. 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 United States. 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?
Rate of participants who complete audiologic follow-up (time frame: Through completion of follow-up (estimated to be 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.