Study on the Impact of Cisplatin and Drug Combination on Speech and Cognition in Cancer Patients

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What is this study about?

This clinical trial is focused on studying the effects of different cancer treatments on how well people can understand speech in noisy environments, as well as their thinking abilities and overall quality of life. The study involves patients diagnosed with cancer who are receiving treatments aimed at curing the disease. The treatments being studied include medications such as cisplatin, oxaliplatin, gemcitabine, capecitabine, mesna, ifosfamide, etoposide, and bleomycin. These medications are administered either through intravenous infusion, which means they are given directly into a vein, or orally in the form of tablets.

The purpose of the study is to assess the short-term effects of these cancer treatments on speech perception in noise. Participants will undergo various assessments to measure changes in their ability to understand speech in noisy settings, as well as changes in their hearing and cognitive functions. The study will also evaluate the impact of these treatments on the participants’ quality of life related to hearing. The trial will follow participants from the start of their treatment and include follow-up visits to monitor any changes over time.

By participating in this study, researchers aim to gain a better understanding of how cancer treatments affect important aspects of daily life, such as communication and cognitive abilities. This information could help improve future treatment plans and support services for individuals undergoing cancer therapy. The study is expected to continue until the end of 2031, with recruitment starting in August 2024.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, which is to assess the short-term effect of different cancer treatments on speech perception in noise.

You will be required to provide written informed consent, confirming your understanding and willingness to participate.

2 initial assessment

An initial assessment will be conducted to establish a baseline for your speech perception in noise and other related cognitive functions.

This assessment will include the Finnish matrix sentence test and other standardized tests to evaluate your hearing and cognitive abilities.

3 treatment phase

During the treatment phase, you will receive cancer treatments that may include medications such as cisplatin, gemcitabine, oxaliplatin, capecitabine, mesna, ifosfamide, etoposide, and bleomycin sulfate.

These medications will be administered through intravenous infusion or oral use, depending on the specific treatment plan designed for you.

The frequency and dosage of these medications will be determined by your healthcare provider based on your individual treatment needs.

4 follow-up visit

Approximately 3-4 months after the end of the initial treatment, a follow-up visit will be scheduled.

During this visit, changes in your speech perception in noise will be measured again using the Finnish matrix sentence test.

Additional assessments may be conducted to evaluate any changes in your hearing and cognitive functions.

5 long-term monitoring

Long-term monitoring will be conducted to assess any ongoing changes in your speech perception in noise, hearing, and cognitive functions.

This may involve periodic assessments and questionnaires to evaluate your hearing-related quality of life and cognitive function over time.

Who Can Join the Study?

Age between 18 and 75 years old
Have a diagnosis of cancer that will be treated with the aim to cure it using one of the following:
- Cisplatin – a type of chemotherapy drug
- Oxaliplatin – another type of chemotherapy drug
- Cisplatin-based chemoradiation therapy for the head and neck area – a combination of chemotherapy and radiation therapy
- Radiation therapy for the head and neck area – treatment using high-energy rays
Have hearing ability that is normal for your age, based on the ISO standard 7029:2017 – a guideline for hearing levels
Be able to provide written informed consent, which means you understand the study and agree to participate
Be a native Finnish speaker

Who Cannot Join the Study?

Patients who do not have a diagnosis of cancer.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Turku University Hospital	Turku	Finland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	15.08.2024

Trial locations

Investigated drugs:

Medication A is a treatment used in cancer therapy. It works by targeting and destroying cancer cells in the body. This medication helps to slow down or stop the growth of cancer cells, which can improve the patient’s condition and potentially lead to recovery. It is administered under the supervision of a healthcare professional, who will monitor its effects and adjust the treatment as needed.

Medication B is another type of cancer treatment that helps the body’s immune system fight cancer. It boosts the immune response, making it easier for the body to identify and attack cancer cells. This medication is part of a broader treatment plan and is used to enhance the effectiveness of other cancer therapies. It is given by a healthcare provider who will ensure it is working properly and manage any side effects.

Therapy C is a supportive treatment aimed at improving the quality of life for cancer patients. It focuses on helping patients manage symptoms and side effects of cancer and its treatments, such as fatigue, pain, and emotional distress. This therapy may include counseling, physical therapy, and other supportive measures to help patients cope with their condition and maintain a better quality of life during treatment.

Investigated diseases:

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. It can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. As cancer progresses, it can invade nearby parts of the body and spread to other areas through the blood and lymph systems. The progression of cancer varies depending on the type and location, but it generally involves stages that describe the size of the tumor and the extent of its spread. Early stages may involve localized tumors, while advanced stages can include metastasis to distant organs. The symptoms and progression can differ significantly between different types of cancer.

Trial ID:

2024-513437-21-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Impact of Cisplatin and Drug Combination on Speech and Cognition in Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?