Not recruitingRare disease

Study Comparing Weekly Low Dose Cisplatin to High Dose Every Three Weeks for Sarcopenic Patients with Head and Neck Cancer

Verified siteRegistered drugNo placebo

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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 a type of cancer called head and neck squamous cell carcinoma, which is a cancer that occurs in the moist tissues of the head and neck. The study is particularly interested in patients who have a condition known as sarcopenia, which means they have low muscle mass. The treatment being tested in this trial is a medication called cisplatin, which is commonly used in chemotherapy to treat various types of cancer. In this study, two different dosing schedules of cisplatin are being compared: a low dose given weekly and a high dose given every three weeks.

The purpose of the study is to see if giving a low dose of cisplatin every week helps patients stick to their treatment plan better than the high dose given every three weeks. The study will involve patients receiving either the weekly low dose or the three-weekly high dose of cisplatin, along with their regular cancer treatment. The researchers will monitor how well patients can follow their treatment schedule and any side effects they experience. The study will also look at other factors like the total amount of cisplatin received, the time it takes for the cancer to come back, and the overall survival of the patients over two years.

Throughout the study, the medical team will keep track of any side effects or toxicities that patients might experience, especially those that are severe. They will also consider the quality of life of the patients and their preferences regarding the treatment. The study aims to provide valuable information on the best way to use cisplatin in treating head and neck cancer in patients with low muscle mass, potentially improving treatment outcomes and patient well-being.

The research process

The trial runs in 5 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. This includes being 18 years or older, understanding Dutch and medical consequences, and being planned for primary cisplatin chemoradiation therapy (CRT) by the treating physician.
Step 2
Treatment plan
The study involves two treatment plans for patients with locally advanced head and neck squamous cell carcinoma. The first plan is a low dose of cisplatin administered weekly. The second plan is a high dose of cisplatin administered every three weeks.
Cisplatin is given as a solution for infusion, which means it is delivered directly into the bloodstream through a vein (intravenous use).
Step 3
Treatment administration
For the weekly low dose plan, cisplatin is administered once every week. For the high dose plan, cisplatin is administered once every three weeks.
The treatment continues as per the schedule unless there is a need for dose reduction, treatment postponement, or termination due to side effects.
Step 4
Monitoring and evaluation
Throughout the trial, compliance with the treatment plan is monitored. Compliance is defined as the absence of significant side effects that require a dose reduction of 50% or more, a treatment delay of 4 days or more, or stopping the treatment after the first or second cycle.
Secondary outcomes such as adverse events, cumulative dose of cisplatin, time to cancer recurrence, overall survival over two years, costs, quality of life, and patient preferences are also evaluated.
Step 5
Completion of the trial
The trial is expected to conclude by November 1, 2027. At the end of the trial, the collected data will be analyzed to determine the effectiveness and safety of the treatment plans.

Who can join the trial?

4 criteria

The patient must have a condition called locally advanced head and neck squamous cell carcinoma. This is a type of cancer that affects the head and neck area.
The patient must be considered eligible and planned for primary cisplatin CRT by their treating physician. Cisplatin CRT is a treatment that combines chemotherapy with radiation therapy.
The patient must be eighteen years of age or older.
The patient must have a sufficient understanding of Dutch and the medical consequences to give informed consent. Informed consent means they understand the study and agree to participate.

Who cannot join the trial?

9 criteria

Patients who have a different type of cancer than the one being studied.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have a medical condition that could interfere with the study results.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medication or its ingredients.
Patients who have a history of severe reactions to similar treatments.
Patients who are unable to provide informed consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Cisplatin: This medication is used in chemotherapy to treat various types of cancer, including head and neck squamous cell carcinoma. In this trial, cisplatin is being tested in two different dosing schedules. One group of patients receives a low dose of cisplatin weekly, while another group receives a higher dose every three weeks. The study aims to determine if the weekly low dose improves treatment adherence in patients with low skeletal muscle mass compared to the standard three-weekly high dose.

Cisplatin

What is already known about the treatment

Cisplatin – Cisplatin is administered intravenously and is used in the treatment of various cancers, including locally advanced head and neck squamous cell carcinoma. It is a well-established chemotherapy drug in medical literature, often used in combination with other treatments. The main therapeutic indication for cisplatin is its ability to treat different types of cancer by interfering with the DNA of cancer cells, preventing them from dividing and growing. At the molecular level, cisplatin forms cross-links with DNA, which disrupts DNA replication and transcription, leading to cell death. It is classified as an alkylating agent, specifically a platinum-based chemotherapy drug.

Investigated diseases

Locally Advanced Head and Neck Squamous Cell Carcinoma – This is a type of cancer that occurs in the squamous cells lining the moist surfaces inside the head and neck. It is considered locally advanced when the cancer has spread from its original site to nearby tissues or lymph nodes but not to distant parts of the body. The progression of this disease can involve the growth of tumors in areas such as the throat, mouth, or nasal passages, potentially affecting speech, swallowing, and breathing. As the disease advances, it may cause noticeable lumps, persistent sore throat, or changes in voice. The condition is often associated with risk factors like tobacco use and human papillomavirus (HPV) infection. Early detection and monitoring are crucial for managing the disease effectively.