Ototoxicity Screening for Head and Neck Cancer Survivors

Recruiting at 1 trial location

Overseen By David Lee, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Recent audiologist, Hearing aid, Cochlear implant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new hearing check-up process for individuals who survived head and neck cancer and underwent cisplatin-based chemoradiation therapy. The trial will assess whether the Ototoxicity Screening Protocol is user-friendly and integrates well into regular follow-up visits. Suitable participants include head and neck cancer survivors who received this treatment and have not had a hearing check-up in the past year. Participants will complete a survey, undergo the hearing check-up before their clinic visit, receive counseling, and may be referred to an audiologist. The trial will monitor each participant's progress for at least six months through their medical records. As an unphased trial, this study allows participants to contribute to enhancing follow-up care for future cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ototoxicity screening protocol is safe for head and neck cancer survivors?

Research shows that checking for hearing problems is generally safe and useful for spotting early signs of hearing loss from treatments like chemotherapy and radiotherapy. This screening identifies hearing damage in cancer survivors who underwent treatments that might affect their ears. Studies have found that this screening usually doesn't cause any harm or discomfort. It helps catch hearing issues early, leading to better care and management. Prospective participants in this trial can feel assured about safety. The process is easy to handle and aims to detect problems early to maintain ear health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ototoxicity screening protocol for head and neck cancer survivors because it offers a comprehensive approach to detecting hearing issues early. Unlike standard care, which often involves waiting for symptoms to appear, this protocol proactively screens patients before they notice hearing loss. It also includes counseling and referrals to audiology, ensuring patients receive timely care. Additionally, the protocol evaluates patient outcomes with follow-up surveys, helping to improve long-term quality of life and hearing health.

What evidence suggests that this ototoxicity screening protocol is effective for head and neck cancer survivors?

Research has shown that hearing damage commonly affects 40-80% of head and neck cancer patients treated with cisplatin-based chemoradiation therapy. This trial will use an Ototoxicity Screening Protocol to enhance follow-up care for these patients. Early detection through this screening identifies hearing loss promptly, enabling timely intervention. This method safely and effectively identifies hearing issues caused by cancer treatments. Overall, hearing screening serves as a valuable tool for managing potential hearing loss in cancer survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

David Lee, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had cisplatin-based chemoradiation therapy to treat head and neck cancer. It's not for those who use hearing aids, have cochlear implants, can't fill out forms in English, or saw an audiologist in the last year.

Inclusion Criteria

I have had cisplatin-based treatment or radiotherapy for head and neck cancer.

Exclusion Criteria

Use of a hearing aid

Patient has been evaluated by an audiologist within the past 12 months

Received a cochlear implant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ototoxicity Screening Protocol

Participants complete a pre-screening survey, ototoxicity screening protocol, and implementation outcome surveys before their survivorship clinic visit. They receive counseling on ototoxicity and referral to audiology during the visit, and complete SESMQ and WU-QOLv4 surveys and undergo pure tone audiometry after the visit.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for audiologic follow-up through chart review for at least six months.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Ototoxicity Screening Protocol

Trial Overview The study is testing a special screening process to check for hearing damage (ototoxicity) in people who've been treated for head and neck cancers with a specific chemotherapy drug.

How Is the Trial Designed?

Group I: Ototoxicity Screening Protocol Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

American Academy of Otolaryngology-Head and Neck Surgery Foundation

Collaborator

Trials

10

Recruited

1,300+

Published Research Related to This Trial

About 20% of testicular cancer patients treated with cisplatin experience persistent ototoxicity, with symptoms like tinnitus and hearing loss, and this risk increases significantly with higher cumulative doses of cisplatin (over 400 mg/m²).

A history of noise exposure is a significant risk factor for developing cisplatin-induced ototoxicity, increasing the likelihood of hearing issues by three times, highlighting the need for careful monitoring and potential preventive strategies in at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of risk factors for cisplatin-induced ototoxicity in patients with testicular cancer. Bokemeyer, C., Berger, CC., Hartmann, JT., et al.[2022]

The COMP-VA program is designed to monitor and prevent hearing loss and tinnitus in Veterans receiving cisplatin, addressing a significant issue as over half of these patients experience permanent hearing changes.

This program utilizes an individualized prediction model and innovative portable audiometry to assess hearing during treatment, aiming to maintain the quality of life for Veterans while effectively managing their cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposed comprehensive ototoxicity monitoring program for VA healthcare (COMP-VA). Konrad-Martin, D., Reavis, KM., McMillan, G., et al.[2022]

An international consensus has been established for monitoring hearing loss in children undergoing potentially ototoxic cancer treatments, emphasizing the need for baseline assessments and regular audiologic follow-ups during therapy.

Children receiving treatments like platinum agents or cranial irradiation should have age-appropriate hearing tests before and after treatment, with additional assessments ideally conducted before each cycle of cisplatin to ensure timely intervention and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for Age-Appropriate Testing, Timing, and Frequency of Audiologic Monitoring During Childhood Cancer Treatment: An International Society of Paediatric Oncology Supportive Care Consensus Report. Meijer, AJM., van den Heuvel-Eibrink, MM., Brooks, B., et al.[2022]

In a study of 103 head and neck cancer patients treated with high-dose cisplatin, 41% experienced significant audiometric changes that led to a change in treatment, highlighting the importance of monitoring hearing health during cancer therapy.

Switching to less ototoxic treatments like carboplatin or reducing the cisplatin dose did not negatively impact treatment outcomes, suggesting that audiometric assessments can help manage hearing loss without compromising cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Audiometry prior to High-Dose Cisplatin in Patients with Head and Neck Cancer. Caballero, M., Mackers, P., Reig, O., et al.[2017]

Ototoxicity, which can lead to irreversible hearing loss, affects 30-40% of patients undergoing radiotherapy for head and neck cancer, highlighting the need for effective prevention strategies.

Primary prevention measures include limiting radiation doses to the cochlea and considering alternative chemotherapy options like carboplatin or cetuximab to reduce the risk of hearing loss, along with monitoring and evaluating individual risk factors before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ototoxicity in head and neck cancers after radiotherapy and chemoradiotherapy: From primary prevention to tertiary prevention]. Espenel, S., Garcia, MA., Guy, JB., et al.[2017]

In a study of 24 patients with head and neck neoplasms, cisplatin (DDP) was found to cause dose-related and irreversible hearing impairment, particularly affecting higher frequencies.

The study suggests that ototoxic screening should be prioritized for patients considered 'at risk' and those receiving more than 400 mg of DDP, as vestibular toxicity was rare and only documented in one case.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ototoxicity of low- and moderate-dose cisplatin. Schaefer, SD., Post, JD., Close, LG., et al.[2022]

In a study of 276 adult survivors of childhood cancer treated with radiotherapy, 19 out of 51 patients showed severe hearing impairment after a median follow-up of 16.6 years, indicating significant ototoxic effects of radiotherapy.

Hearing loss can develop over time, as evidenced by five patients who initially had normal hearing but later showed impairment, highlighting the need for regular audiology screenings and interventions for survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing Loss in Adult Survivors of Childhood Cancer Treated with Radiotherapy. Khan, A., Budnick, A., Barnea, D., et al.[2020]

In a study of 50 pediatric cancer survivors who received ototoxic therapy, 60% failed vestibular screening, indicating a high prevalence of vestibular issues in this population.

Children with brain tumors and those who underwent brain surgery were at a significantly higher risk for vestibular screening failures, highlighting the need for targeted screening in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the prevalence of vestibular screening failures in pediatric cancer patients whose therapies include radiation to the head/neck and platin-based therapies: A pilot study. Camet, ML., Hayashi, SS., Sinks, BC., et al.[2020]

Weekly dosing of cisplatin significantly reduces the risk of ototoxicity in patients with head and neck squamous cell carcinoma, while maintaining similar progression-free and overall survival rates compared to high-dose cisplatin.

Genetic factors such as the COMT and MATE1 genes can predict ototoxicity risk, with COMT carriers at higher risk and MATE1 A/A carriers showing protection, suggesting that genotyping could help tailor treatment to minimize hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of cisplatin-induced ototoxicity and survival in chemoradiation treated head and neck cancer patients. Teft, WA., Winquist, E., Nichols, AC., et al.[2021]

In a study of 270 childhood cancer survivors treated with platinum-based chemotherapy, 75% experienced some level of hearing loss, highlighting a significant long-term side effect of this treatment.

Younger age at diagnosis, higher doses of cisplatin, earlier treatment years, and additional therapies like cranial radiation and stem cell transplantation were identified as key risk factors for more severe hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severity of hearing loss after platinum chemotherapy in childhood cancer survivors. Strebel, S., Mader, L., Sláma, T., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973582/

Ototoxicity Monitoring: The Evolution of a Protocol for Head ... Our study demonstrated a marked improvement in audiologic follow‐up with the implementation of an OMP; specifically, the proportion of patients ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04790

Ototoxicity Screening Protocol for Head and Neck Cancer ... This trial tests the effectiveness of a hearing screening testing protocol to detect hearing loss or damage (ototoxicity) in head and neck cancer survivors ...

3. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-3-2023-38386

Ototoxicity Screening for Head and Neck Cancer Survivors Ototoxicity screening is generally safe and helps in early detection of hearing loss caused by cancer treatments like chemotherapy and radiotherapy.

4. researchposters.com researchposters.com/Posters/COSM/COSM2025/B344.pdf

Effectiveness and Feasibility of an Ototoxicity Screening ... Cisplatin-based chemoradiation therapy causes irreversible ototoxicity in 40-80% of treated patients. • AHNS survivorship consensus statement suggests ...

5. researchprotocols.org researchprotocols.org/2025/1/e71562/PDF

Comparative Study of the Quality of Life of Patients With A recent study estimated the prevalence of ototoxicity and its associated risk factors in a cohort of 145 testicular cancer survivors who ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7995701/

Insight into the current practice of ototoxicity monitoring during ... The aim of this study is to evaluate the current state of ototoxicity monitoring for patients receiving cisplatin chemotherapy in an academic medical center.

7. turkarchotolaryngol.net turkarchotolaryngol.net/articles/long-term-prospective-comparative-analysis-of-ototoxic-and-survival-outcomes-of-sequential-boost-and-simultaneous-integrated-boost-of-volumetric-modulated-arc-therapy-for-head-neck-carcinomas/tao.2024.2023-10-10

Long-term Prospective Comparative Analysis of Ototoxic ... This study aims to explore the ototoxic profile of SIB vs. SEQ VMAT plans in head and neck cancer patients undergoing RT. Secondary objectives include comparing ...