Clinical trial NCT06662058: Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation
Official title: Ototoxicity Monitoring and Remote Audiometry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Cutaneous Squamous Cell Carcinoma of the Head and Neck
Head and Neck Carcinoma of Unknown Primary
Head and Neck Squamous Cell Carcinoma
Hypopharyngeal Squamous Cell Carcinoma
Laryngeal Squamous Cell Carcinoma
Metastatic Cutaneous Squamous Cell Carcinoma of the Head and Neck
Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Hypopharyngeal Squamous Cell Carcinoma
Metastatic Laryngeal Squamous Cell Carcinoma
Metastatic Nasopharyngeal Squamous Cell Carcinoma
Metastatic Oral Cavity Squamous Cell Carcinoma
Metastatic Oropharyngeal Squamous Cell Carcinoma
Metastatic Paranasal Sinus Squamous Cell Carcinoma
Nasopharyngeal Squamous Cell Carcinoma
Oral Cavity Squamous Cell Carcinoma
Oropharyngeal Squamous Cell Carcinoma
Paranasal Sinus Squamous Cell Carcinoma
Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Nasopharyngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Paranasal Sinus Squamous Cell Carcinoma
Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Stage IV Hypopharyngeal Carcinoma AJCC v8
Stage IV Laryngeal Cancer AJCC v8
Stage IV Lip and Oral Cavity Cancer AJCC v8
Stage IV Nasopharyngeal Carcinoma AJCC v8
Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IV Sinonasal Cancer AJCC v8
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-10-28
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation.

Detailed description: PRIMARY OBJECTIVE:

I. To determine whether a targeted intervention of remote audiometry offered to patients with advanced disease or living \> 120 miles away increases overall participation in ototoxicity monitoring.

SECONDARY OBJECTIVE:

I. To estimate the incidence and severity of cisplatin-induced hearing loss in head and neck squamous cell carcinoma (HNSCC).

TERTIARY/EXPLORATORY OBJECTIVE:

I. To identify potential barriers to ototoxicity monitoring participation, from the patient perspective.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo audiometry at Winship Emory Midtown (WEM) at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.

GROUP II: Patients who do not live \> 120 miles away or do not have stage IV disease are assigned to Arm I. Patients who do live \> 120 miles away or who have stage IV disease are assigned to Arm II.

ARM I (USUAL): Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.

ARM II (INTERVENTION): Patients undergo audiometry at WEM at baseline and are offered closer to home audiometry or self-administered remote audiometry at 3 and 12 months after chemotherapy and/or radiation treatment.

Eligibility criteria: Inclusion Criteria:

* Adult patients, male or female, aged ≥ 18, able to provide informed consent
* Subjects with pathologically proven HNSCC involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, skin, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can also be included. Patients can have previously untreated or recurrent/metastatic disease
* Subjects who will be treated with cisplatin chemotherapy and/or radiation. For radiation alone, patients should have tumors near the inner ear, including the nasopharynx, temporal bone, and/or parotid salivary gland
* Life expectancy of more than 3 months, as determined by the investigator

Exclusion Criteria:

* Patients with profound hearing loss in both ears, which precludes an accurate hearing test. This can be determined based on patient report/history or audiogram done before or after informed consent
* Patients who are unable to participate in a hearing test (per the investigator's judgment)

Primary outcomes:
measure: Proportion of patients who complete at least one post-treatment audiogram
timeFrame: Up to 12 months post-treatment
Secondary outcomes:
measure: Incidence and severity of hearing loss
timeFrame: Up to 30 days following cessation of study participation
Other outcomes:
measure: To identify potential barriers to ototoxicity monitoring participation
timeFrame: Up to 18 months post-treatment
Locations:
city: Atlanta
country: United States
facility: Emory Midtown University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Nicole C Schmitt, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: