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Study on Sodium Thiosulfate to Prevent Hearing Loss in Patients with Head and Neck Cancer Receiving Cisplatin Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on preventing hearing loss caused by a cancer treatment drug called cisplatin. The study is specifically for patients with a type of cancer known as head and neck squamous cell carcinoma. The treatment being tested is an injection of sodium thiosulfate, which is combined with a gel called hyaluronate. This mixture is injected directly into the ear to help protect against hearing damage that can occur as a side effect of cisplatin.

The purpose of the study is to see if this treatment can effectively reduce hearing loss in patients receiving cisplatin. Participants in the study will receive the sodium thiosulfate injection through a procedure called a transtympanic injection, which means the medicine is delivered through the eardrum. The study will compare the hearing of the ear that receives the treatment with the ear that does not, to determine if there is a noticeable benefit.

The study will take place over a period of time, with participants receiving the treatment and then having their hearing tested at various points, including three months after the treatment. The goal is to find out if the sodium thiosulfate injection can help maintain better hearing levels compared to not receiving the treatment. This research is important for improving the quality of life for patients undergoing treatment with cisplatin by potentially reducing the risk of hearing loss.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of head and neck cancer requiring cisplatin treatment.
Written informed consent is required to participate.
Step 2
Initial assessment
An initial hearing assessment is conducted to establish a baseline for future comparisons.
This assessment helps in evaluating the effectiveness of the treatment in preventing hearing loss.
Step 3
Treatment phase
The treatment involves the administration of sodium thiosulfate through a transtympanic injection.
This is done to prevent hearing loss associated with cisplatin, a chemotherapy drug.
The dosage of cisplatin is either 40 mg/m² weekly for 7 cycles or 100 mg/m² every 3 weeks for 3 cycles, with a cumulative dose of at least 200 mg/m².
Step 4
Follow-up assessments
Hearing assessments are conducted at various intervals to monitor changes in hearing ability.
The primary goal is to determine if there is a significant improvement in hearing thresholds in the treated ear compared to the untreated ear.
Step 5
Final evaluation
A final hearing assessment is performed three months after the treatment to evaluate the long-term effects.
The results are compared to the initial baseline to assess the effectiveness of the treatment.
Step 6
Quality of life assessment
Quality of life and patient-related outcomes are measured using questionnaires.
These include the Speech, Spatial and Qualities of Hearing scale and the Tinnitus Handicap Inventory.

Who can join the trial?

5 criteria

Must have a confirmed diagnosis of a solid head and neck cancer that requires treatment with a specific chemotherapy drug called cisplatin.
Must be receiving a high dose of cisplatin, which means a total amount of at least 200 mg per square meter of body surface area, given in either 7 smaller doses or 3 larger doses.
Must be able and willing to sign a document that shows you understand the study and agree to participate, known as informed consent.
Must have a WHO performance status of 0, 1, or 2, which is a way to measure how well you can perform daily activities. A status of 0 means fully active, 1 means some symptoms but still able to do light work, and 2 means unable to work but able to take care of yourself.
Must be older than 18 years.

Who cannot join the trial?

7 criteria

Patients with a history of **allergic reactions** to any of the study medications cannot participate. An allergic reaction is when your body reacts badly to something, like a rash or trouble breathing.
Patients who are currently taking other medications that might interfere with the study treatment are not eligible. This means if you are on certain drugs that could affect how the study medicine works, you cannot join.
Patients with **severe hearing loss** that is not related to the study condition are excluded. Severe hearing loss means you have a lot of trouble hearing, and it's not because of the condition being studied.
Patients who have had recent ear surgery are not allowed to participate. Recent means any surgery on your ear that happened not long ago.
Patients with other serious health conditions that might affect the study results cannot join. This means if you have another major illness that could change how the study works, you cannot be part of it.
Pregnant or breastfeeding women are excluded from the study. This means if you are expecting a baby or nursing, you cannot take part.
Patients who are unable to follow the study procedures or attend the required visits are not eligible. This means if you cannot keep up with the study schedule or come to the appointments, you cannot join.

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Verified sites

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Responsive
Academisch Ziekenhuis Leiden
Leiden, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

Sodium Thiosulfate (STS) is being tested in this trial to see if it can help prevent hearing loss caused by a chemotherapy drug called cisplatin. The medication is administered transtympanically, which means it is delivered directly into the middle ear. The goal is to protect the ears from the harmful effects of cisplatin without affecting the cancer treatment.

Sodium Thiosulfate

What is already known about the treatment

Sodium Thiosulfate – This medication is administered transtympanically, meaning it is delivered directly into the middle ear. It is currently being studied in clinical trials to evaluate its effectiveness in preventing hearing loss caused by cisplatin, a chemotherapy drug. The main therapeutic indication for sodium thiosulfate in this context is to protect against ototoxicity, which is hearing damage due to medication. At the molecular level, sodium thiosulfate works by neutralizing reactive oxygen species and binding to harmful platinum compounds, reducing their toxic effects on the inner ear. It is classified pharmacologically as an antidote and protective agent.

Investigated diseases

Head and Neck Squamous Cell Carcinoma – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a small, localized growth or sore that does not heal. As the disease progresses, it can invade nearby tissues and spread to lymph nodes in the neck. Symptoms may include a persistent sore throat, difficulty swallowing, and changes in voice. The disease can also cause visible lumps or sores in the mouth or throat. Over time, it may spread to other parts of the body if not managed.