Ototoxicity Screening for Head and Neck Cancer Survivors

Overseen by David Lee, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Washington University School of Medicine

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the Ototoxicity Screening Protocol treatment for head and neck cancer survivors?

The research highlights the importance of ototoxicity monitoring during treatment to manage and reduce long-term hearing loss in head and neck cancer patients. Programs like COMP-VA, which include comprehensive ototoxicity monitoring, have been developed to predict and manage hearing loss in patients receiving treatments like cisplatin, suggesting that similar screening protocols could be effective in reducing ototoxicity. ^{1 2 3 4 5}

Is ototoxicity screening safe 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. Monitoring during treatment can reduce long-term impacts, and specific measures can be taken to prevent or manage hearing loss. ^{2 6 7 8 9}

How does the treatment for ototoxicity in head and neck cancer survivors differ from other treatments?

This treatment focuses on preventing and monitoring hearing loss caused by radiotherapy and chemotherapy, particularly by managing the dose of radiation to the cochlea and using alternative chemotherapy drugs like carboplatin-5-fluorouracil or cetuximab instead of high-dose cisplatin. It emphasizes early detection and management of hearing issues to reduce long-term impact, which is not typically a focus in standard treatments. ^{1 2 3 7 10}

Research Team

David Lee, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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 am 18 years old or older.

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

Exclusion Criteria

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

Use of a hearing aid

Received a cochlear implant

Trial Timeline

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

Treatment Details

Interventions

• Ototoxicity Screening Protocol (Other)

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.

Participant Groups

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+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

American Academy of Otolaryngology-Head and Neck Surgery Foundation

Collaborator

Trials

10

Recruited

1,300+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Predictors of cisplatin-induced ototoxicity and survival in chemoradiation treated head and neck cancer patients. [2021]

2. France pubmed.ncbi.nlm.nih.gov

[Ototoxicity in head and neck cancers after radiotherapy and chemoradiotherapy: From primary prevention to tertiary prevention]. [2017]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Hearing Loss in Adult Survivors of Childhood Cancer Treated with Radiotherapy. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Audiometry prior to High-Dose Cisplatin in Patients with Head and Neck Cancer. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Proposed comprehensive ototoxicity monitoring program for VA healthcare (COMP-VA). [2022]

6. United States 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Ototoxicity of low- and moderate-dose cisplatin. [2022]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Severity of hearing loss after platinum chemotherapy in childhood cancer survivors. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Analysis of risk factors for cisplatin-induced ototoxicity in patients with testicular cancer. [2022]