RecruitingOBSERVATIONAL

Radiotherapy of Head and Neck Cancer With SIB

This study investigates a type of radiotherapy called Simultaneous Integrated Boost (SIB) for people with head and neck cancer. Doctors want to see how effective and safe this treatment is, whether it's used as the main treatment or after surgery. They will monitor if the cancer stays away, how long people live, and how often the cancer spreads. A key part of the study is looking at side effects and how the treatment affects quality of life, using special questionnaires. This is a "real-world" study, meaning it observes how this treatment is used in everyday hospital care, rather than testing something brand new. The goal is to improve understanding and treatment for head and neck cancer patients.

At a glance

Status

Recruiting

Sponsor

Wuerzburg University Hospital

Enrolment target

750

Start

21 May 2019

Estimated completion

01 Oct 2039

Quality of Life (QOL)Head and Neck Cancer Radiotherapy Side Effect Radiotherapy, Conformal (IMRT)

What is this study about?

This study is about a special type of radiation treatment called Simultaneous Integrated Boost (SIB) for people who have head and neck cancer. You might have head and neck cancer in places like your mouth, throat, or voice box. Radiotherapy uses high-energy beams to kill cancer cells, and SIB is a modern way to deliver this treatment.

Doctors want to understand if SIB radiotherapy is a really effective and safe treatment. They are looking at how well it stops the cancer from coming back, how long people live after treatment, and whether the cancer spreads to other parts of the body. They also want to see what kind of side effects people experience and how that affects their daily life. This is really important because treatments shouldn't just fight cancer; they should also help you maintain your quality of life.

This isn't a study where doctors are trying out a brand-new, unproven treatment. Instead, it's a "real-world" study, which means they are carefully observing and collecting information about how SIB radiotherapy is helping people who are already receiving this treatment as part of their standard care. The information gathered from this study will help doctors across the UK and beyond better understand the actual benefits and challenges of SIB radiotherapy, leading to improved care for future patients.

Key takeaways

This study helps understand a common radiotherapy for head and neck cancer.
It measures how well the treatment works and what side effects people have.
Your quality of life during and after treatment is a key focus.
You'd simply receive your planned treatment and fill out questionnaires.
Your participation helps improve care for future patients.
You can stop participating at any time without affecting your care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with a type of head and neck cancer. This means you have a confirmed head and neck cancer that is not a basal cell carcinoma (a common type of skin cancer). You must also be planning to have radiotherapy, or radiotherapy combined with chemotherapy, as your main treatment or after surgery, at the University Hospital Würzburg.

There are also a few reasons why you might not be able to join. For example, if you haven't given your permission to take part, or if you have a medical or mental health condition that would make it very difficult for you to understand the study information or fill out forms. The doctors also need to believe you would be able to follow the study's requirements.

If you think you meet these requirements and are interested, it's always best to talk to your doctor. They can give you the most accurate advice based on your personal health situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed head and neck cancer (not basal cell skin cancer)?
Are you receiving radiotherapy (or chemo-radiotherapy) at University Hospital Würzburg?
Are you able to understand study information and fill out forms?
Have you given your permission to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given any new or experimental medicines. You will receive the standard radiotherapy treatment for your head and neck cancer, which includes the special SIB technique. The main thing you'll do for the study is fill out some questionnaires. These questionnaires will ask you about your quality of life, how you're feeling, and any side effects you might be experiencing from the treatment.

You'll complete these questionnaires at a few key times: before you start your treatment, right after your treatment finishes, and then during your regular follow-up appointments with your doctor. This allows the study team to see how your quality of life and any side effects change over time. The study will last for as long as your regular follow-up care for your head and neck cancer. Your treatment itself will follow national guidelines, and your doctors will decide the specifics based on your cancer and overall health.

Potential risks and benefits

Being part of this study won't change the treatment you receive, as you'll get the standard care for your condition. A potential benefit is that by sharing your experiences, you'll be helping doctors learn more about SIB radiotherapy, which could lead to better outcomes and quality of life for future patients with head and neck cancer. While there are no direct physical risks from participating in the study itself, you might find answering the questionnaires about your symptoms and feelings a bit tiring or emotional at times. Remember, you can choose to stop being part of the study at any time, without it affecting your medical care.

Locations (1)

University Clinic of Wuerzburg
Verified postcode
Würzburg, Germany· Recruiting

Common questions

What is SIB radiotherapy?

SIB stands for Simultaneous Integrated Boost. It's a modern way of delivering radiation treatment that allows doctors to give a higher dose of radiation to the main cancer area, while giving a slightly lower dose to nearby areas where cancer cells might also be, all at the same time.

Will I get a different treatment if I join this study?

No, you will receive the standard radiotherapy treatment for head and neck cancer, which includes the SIB technique, as decided by your doctors. The study is observing this standard treatment, not changing it.

What do the questionnaires ask about?

The questionnaires ask about your general quality of life, and specific things related to head and neck cancer treatment, like difficulty swallowing, speaking, dry mouth, taste changes, and pain.

How long will I be involved in the study?

You'll be involved throughout your treatment and during your regular follow-up appointments, which means the duration will depend on your specific care plan.

Can I leave the study if I change my mind?

Yes, you are completely free to withdraw from the study at any time, and it will not affect your medical care.

How to find out more

Victor Lewitzki, MD, PhD

lewitzki_v@ukw.de +49-931-201-28869 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.