Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation

Официальное название

Ototoxicity Monitoring and Remote Audiometry

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Audiometric Test
  Undergo audiometry
• Процедура Audiometric Test
  Undergo close to home audiometry
• Процедура Audiometric Test
  Undergo self-administered remote audiometry
• Другое Interview
  Ancillary studies

Первичные конечные точки

• Proportion of patients who complete at least one post-treatment audiogram [Срок оценки: Up to 12 months post-treatment]

Вторичные конечные точки (1)

• Incidence and severity of hearing loss [Срок оценки: Up to 30 days following cessation of study participation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Emory Midtown University Hospital/Winship Cancer Institute — Atlanta

Идентификаторы

NCT: NCT06662058 · STUDY00008286 · K24DC022077 · P30CA138292 · NCI-2024-08456 · STUDY00008286 · WINSHIP6359-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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