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

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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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

3 criteria

  • 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.
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Investigated drugs

Cancer therapies These are various medical treatments used to fight cancer. In this study, different types of cancer therapies are being examined to see how they affect the ability to understand speech in noisy environments. These treatments may consist of chemotherapy (medicines that attack cancer cells), radiation therapy (targeted radiation to destroy cancer cells), or other forms of cancer treatment. The goal of these therapies is to treat the cancer and improve patients' health. This research looks specifically at how these treatments can affect hearing and the ability to follow conversations in noisy situations.

What is already known about the treatment

  • Cisplatin

    Cisplatin is one of the most widely used chemotherapy agents and is given as an infusion (drip) into a vein, typically in cycles a few weeks apart. It has been a cornerstone of cancer treatment for decades and is used, among other things, against testicular cancer, lung cancer, bladder cancer and cancers of the head and neck region. The drug contains platinum and works by binding to the DNA of cancer cells and forming cross-links that prevent the cells from copying their genetic material and dividing, after which they die. Cisplatin belongs to the group of platinum-based cytotoxic agents (alkylating chemotherapy).

  • Gemcitabine

    Gemcitabine is a well-known chemotherapy agent given as an infusion into a vein, usually once a week in set cycles. It is used widely against several types of cancer, including pancreatic cancer, lung cancer, bladder cancer and breast cancer. The drug resembles one of the natural building blocks of DNA and is incorporated into the DNA of cancer cells during cell division, which stops the copying of the genetic material and causes the cells to die. Gemcitabine belongs to the group of antimetabolites (nucleoside analogues).

  • Oxaliplatin

    Oxaliplatin is a well-documented chemotherapy agent given as an infusion into a vein over a couple of hours, often together with other cancer medicines. It is standard treatment for colon and rectal cancer and is also used in other cancers of the gastrointestinal area. Like cisplatin, it contains platinum and works by forming cross-links in the DNA of cancer cells so that the cells cannot divide and eventually die. Oxaliplatin belongs to the group of platinum-based cytotoxic agents.

  • Capecitabine

    Capecitabine is a chemotherapy agent in tablet form, taken by mouth twice a day, which makes treatment at home possible. It is well established in the treatment of colon cancer, breast cancer and stomach cancer, among others. Capecitabine is a so-called prodrug, which is only converted inside the body – and especially in the cancer cells – into the active substance 5-fluorouracil, which inhibits the formation of DNA building blocks and thereby stops the division of the cancer cells. The medicine belongs to the group of antimetabolites.

  • Mesna

    Mesna is not a cancer medicine in itself, but a protective medicine given as an injection or infusion into a vein in connection with certain chemotherapy treatments. It is used routinely together with ifosfamide and high doses of cyclophosphamide to prevent bladder damage and bleeding from the bladder. The substance works by binding to the harmful breakdown products of the chemotherapy in the urine and neutralising them before they can irritate the lining of the bladder. Mesna is classified as a detoxifying agent (a protective agent used with chemotherapy).

  • Ifosfamide

    Ifosfamide is a well-known chemotherapy agent given as an infusion into a vein, often over several days in each treatment cycle. It is used, among other things, against sarcomas (cancers of the bone and soft tissue), testicular cancer and lymphoma. The substance is converted in the liver into active compounds that bind to the DNA of cancer cells and form cross-links, so that the cells cannot copy their genetic material and divide. Ifosfamide belongs to the group of alkylating cytotoxic agents.

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 detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513437-21-00Estimated enrolment250 patientsSponsorTurku University Hospital

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