Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
This study, called PRESERVE, looks at people who have had surgery for a type of mouth cancer called oral cavity squamous cell carcinoma. After surgery, some patients need radiotherapy to help prevent the cancer from coming back. This study compares two different approaches to giving this radiotherapy, specifically focusing on how much of the neck area receives treatment. The main goal is to find out which radiotherapy method leads to a better quality of life, especially regarding problems with swallowing. We hope to gather strong evidence to help doctors choose the best treatment for future patients with similar conditions. It's a randomised study, meaning participants will be assigned to one of the treatment groups by chance.
At a glance
What is this study about?
When you have surgery for a type of mouth cancer, sometimes doctors recommend radiotherapy afterwards. This is like a targeted treatment using X-rays to help kill off any remaining cancer cells and stop the cancer from coming back. This study, called PRESERVE, focuses on how much of the neck area should receive this radiotherapy, particularly for patients who have had some lymph nodes removed and found to be clear of cancer.
The main question we're trying to answer is: does giving radiotherapy to a smaller, more targeted area of the neck, rather than a larger area, help patients keep their ability to swallow better and improve their overall quality of life? Swallowing problems can be a common side effect of cancer treatments, and this study aims to find a way to reduce that impact while still effectively treating the cancer.
To do this, we will compare quality of life in two groups of patients. One group will receive the standard radiotherapy to the tumour area and surrounding parts of the neck. The other group will receive a more targeted radiotherapy, focusing only on the tumour area. By comparing these two approaches, we hope to find clearer guidance for doctors on which treatment option is best for these specific patients.
Key takeaways
- This study compares two radiotherapy methods for mouth cancer after surgery.
- The main goal is to improve swallowing and quality of life for patients.
- It aims to provide clearer guidance for doctors on best treatment choices.
- You would be randomly assigned to one of the two treatment groups.
- Your progress and quality of life will be checked for five years.
- The study focuses on certain patients whose lymph nodes were clear after surgery.
Who may be eligible?
To join this study, you would need to be an adult over 18 who has recently had surgery for a type of mouth cancer called oral cavity squamous cell carcinoma. A key point is that your cancer must have certain features that mean your doctor recommends a type of radiotherapy after surgery. Also, at least one side of your neck, where lymph nodes were removed, must have been found to be clear of cancer.
There are also some things that would mean you can't join. For example, if you have other serious health problems, have had head and neck cancer before in the last five years, or have had radiotherapy to your head or neck in the past. If your cancer has spread to other parts of your body, or if you're pregnant or breastfeeding, you wouldn't be able to participate. It's also important that you'd be able to attend all your appointments and fill out questionnaires about your quality of life.
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.
- Have you recently had surgery for mouth cancer?
- Has your doctor said you need radiotherapy after your surgery?
- Are some of your neck lymph nodes clear of cancer after surgery?
- Are you generally well and able to attend appointments?
- Are you aged 18 or over?
- Have you NOT had other head and neck cancers or radiotherapy recently?
What does participation involve?
If you join this study, you would be randomly assigned to one of two groups, like flipping a coin, to decide which radiotherapy approach you receive. One group will get the standard radiotherapy to the tumour area and surrounding parts of the neck. The other group will receive radiotherapy that is more focused, just on the tumour area.
Both groups will receive their radiotherapy treatment as prescribed. After your treatment, you would be followed by the study team for a total of five years. This follow-up will involve regular check-ups and filling out questionnaires about your quality of life, especially regarding your swallowing and general well-being. These questionnaires are important for the study to understand the differences between the two treatment methods.
Potential risks and benefits
Locations (8)
- Miami Cancer InstituteVerified postcodeMiami, United States· Recruiting
- London Regional Cancer ProgramVerified postcodeLondon, Canada· Recruiting
- CHUMVerified postcodeMontreal, Canada· Recruiting
- Cork University HospitalUnverifiedWilton, Ireland· Recruiting
- University Hospital Galway, Newcastle RoadVerified postcodeGalway, Ireland· Recruiting
- St. Luke's Radiation Oncology NetworkVerified postcodeRathgar, Ireland· Recruiting
- Beaumont St. Luke's CentreVerified postcodeDublin, Ireland· Recruiting
- Beatson West of Scotland Cancer CentreVerified postcodeGlasgow, United Kingdom· Recruiting
Common questions
What is oral cavity squamous cell carcinoma?
It's the most common type of cancer that starts in the mouth area, like the tongue, gums, or lining of the cheek.
What does 'randomised study' mean?
It means you'll be put into one of the treatment groups by chance, like drawing names from a hat. This helps us fairly compare the treatments.
Why is 'quality of life' important in this study?
We want to understand not just how well treatments fight cancer, but also how they affect your daily life, especially important aspects like eating and swallowing.
What are the two types of radiotherapy being compared?
One is the usual radiotherapy covering the tumour and a wider area of the neck. The other is a more targeted radiotherapy, focusing only on the tumour area.
How long will I be involved in the study?
You'll be followed by the study team for five years after your treatment is finished to see how you're doing in the long term.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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