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Trial Title:
Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients with Head and Neck Squamous Cell Cancer Receiving Cisplatin And/or Radiation
NCT ID:
NCT06662058
Condition:
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
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Nasopharyngeal Carcinoma
Squamous Cell Carcinoma of Head and Neck
Laryngeal Neoplasms
Mouth Neoplasms
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Audiometric Test
Description:
Undergo audiometry
Arm group label:
Group I (audiometry)
Arm group label:
Group II, Arm I (audiometry)
Arm group label:
Group II, Arm II (close to home audiometry, remote audiometry)
Other name:
Audiometric Testing
Other name:
Audiometry
Other name:
Hearing Test
Intervention type:
Procedure
Intervention name:
Audiometric Test
Description:
Undergo close to home audiometry
Arm group label:
Group II, Arm II (close to home audiometry, remote audiometry)
Other name:
Audiometric Testing
Other name:
Audiometry
Other name:
Hearing Test
Intervention type:
Procedure
Intervention name:
Audiometric Test
Description:
Undergo self-administered remote audiometry
Arm group label:
Group II, Arm II (close to home audiometry, remote audiometry)
Other name:
Audiometric Testing
Other name:
Audiometry
Other name:
Hearing Test
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Group I (audiometry)
Arm group label:
Group II, Arm I (audiometry)
Arm group label:
Group II, Arm II (close to home audiometry, remote audiometry)
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory Midtown University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Contact:
Last name:
Nicole C. Schmitt
Phone:
404-778-1900
Email:
nicole.cherie.schmitt@emory.edu
Contact backup:
Last name:
Nicole C. Schmitt
Start date:
January 1, 2025
Completion date:
October 31, 2029
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06662058
