Study on SENS-401 to Prevent Hearing Loss Caused by Cisplatin in Adults with Cancer

2 1 1

What is this study about?

This clinical trial is focused on studying a condition known as cisplatin-induced hearing loss, which can occur in patients undergoing treatment for cancer. The study is investigating a new treatment called SENS-401, also known as Arazasetron besylate, which is taken as a film-coated tablet. The purpose of the study is to evaluate whether SENS-401 can help prevent hearing loss caused by the cancer medication cisplatin.

Participants in the study will be adults who are receiving cisplatin as part of their cancer treatment. The study will involve taking SENS-401 at a dose of 43.5 mg twice a day for up to 23 weeks. The effectiveness of SENS-401 in preventing hearing loss will be assessed four weeks after the last dose of cisplatin. Some participants will receive a placebo instead of SENS-401 to compare the outcomes.

The study will monitor changes in hearing ability by measuring hearing thresholds, which are the quietest sounds a person can hear, at various frequencies. This will help determine if SENS-401 is effective in protecting against hearing loss. The trial is expected to continue until March 2025, with participants being recruited since December 2022.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, ability to provide consent, and medical condition.

Participants must be adults with a neoplastic disease scheduled to receive chemotherapy including cisplatin.

2 medication administration

The study involves the administration of SENS-401 at a dose of 43.5 mg taken twice daily (b.i.d., which means ‘bis in die’ or twice a day).

This medication is taken for up to 23 weeks to help prevent hearing loss caused by cisplatin.

3 treatment with cisplatin

Participants receive chemotherapy that includes cisplatin, with a minimum dose of 70 mg/m² per cycle and a total dose of at least 210 mg/m².

The goal is to evaluate the effectiveness of SENS-401 in preventing hearing loss from this treatment.

4 hearing assessment

Hearing is assessed using an audiogram that measures hearing thresholds at frequencies between 0.5 and 12.5 kHz.

This assessment occurs 4 weeks after the last cisplatin treatment to determine any changes in hearing ability.

5 completion of study

The study is expected to conclude by March 31, 2025.

Participants’ hearing data will be analyzed to evaluate the primary endpoint, which is the change in hearing threshold from the baseline.

Who Can Join the Study?

You must be 18 years or older at the time of signing the consent form.
You need to be able to give signed informed consent, which means you understand and agree to the study’s requirements and restrictions.
If you are a female, you must not be pregnant or breastfeeding. You must either not be able to have children or agree to use birth control for at least 30 days after the last dose of the study drug if you do not receive cisplatin, or for 6 months after the last dose of cisplatin.
If you are a male, you must agree to use birth control and not donate sperm for at least 30 days after the last dose of the study drug if you do not receive cisplatin, or for 6 months after the last dose of cisplatin.
You must have a neoplastic disease, which means you have a type of cancer, and you are planned to be treated with a chemotherapy that includes a dose of cisplatin of at least 70 mg/m² per cycle and a total dose of at least 210 mg/m².
Your hearing test results must meet specific criteria: a hearing threshold of 30 decibels (dB) or less at 500 Hz, 40 dB or less at 1-2 kHz, 60 dB or less at 4-6 kHz, and 80 dB or less at 8 kHz, in either both ears or one ear for a maximum of 30% of the subjects in each study group.
The study doctor must believe you have a life expectancy of at least 6 months.

Who Cannot Join the Study?

Patients who have not experienced hearing loss caused by the medication cisplatin cannot participate. Cisplatin is a drug used to treat cancer, and it can sometimes cause hearing problems.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hôpital Européen Georges-Pompidou	Paris	France

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hospital Edouard Herriot	Lyon	France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Centre Medico Chirurgical Ambroise Pare Hartmann	Neuilly-Sur-Seine	France
Hcyliky Pmgmr Lu Bnsm – Rantll Ssikq	Lille	France
Alwxmdpxfn Psphifov Hkbwolaf Dv Pzerh	Paris	France
Hbkqtzj Hcjpj Myamjs &almsce 1 rfd Gnkfrtx Euirqp	Creteil	France
Idfsvqeg dk Csenbgfbkyaj Hiylkgtqqga Uctourrmebgms db Swreu Eytrjsq (coaemic	Saint Priest En Jarez	France
Cucjgx Oppgv Lwdkedx	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.12.2022

Trial locations

Investigated drugs:

R-Azasetron Besilate

SENS-401 is a medication being studied to see if it can help prevent hearing damage caused by another drug called cisplatin. It is given to patients who have cancer and are receiving cisplatin as part of their treatment. The study is looking at how well SENS-401 works when taken for up to 23 weeks.

Cisplatin is a chemotherapy drug used to treat various types of cancer. While it can be effective in fighting cancer, it can also cause side effects, including damage to the ears, which can lead to hearing loss. This study is testing whether SENS-401 can help protect against this side effect.

Investigated diseases:

Deafness

Cisplatin-Induced Hearing Loss – This condition occurs as a side effect of the chemotherapy drug cisplatin, which is used to treat various types of cancer. The drug can damage the inner ear, leading to hearing loss that may affect one or both ears. The hearing loss can range from mild to severe and often involves high-frequency sounds. It typically develops during or shortly after the course of cisplatin treatment. The progression of hearing loss can vary, with some individuals experiencing gradual worsening over time. The condition is more common in patients receiving higher doses or prolonged treatment with cisplatin.

Trial ID:

2024-511713-38-00

Protocol code:

SENS-401-202

NCT ID:

NCT05628233

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on SENS-401 to Prevent Hearing Loss Caused by Cisplatin in Adults with Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?