All studies
RecruitingPHASE2INTERVENTIONAL

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

Status
Recruiting
Phase
PHASE2
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Enrolment target
90
Start
06 Sep 2019
Estimated completion
01 Sep 2026

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.

  1. Have you recently had surgery for mouth cancer?
  2. Has your doctor said you need radiotherapy after your surgery?
  3. Are some of your neck lymph nodes clear of cancer after surgery?
  4. Are you generally well and able to attend appointments?
  5. Are you aged 18 or over?
  6. Have you NOT had other head and neck cancers or radiotherapy recently?
Answer every question to see your result.

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

Participating in this study might offer a potential benefit of receiving a more targeted radiotherapy that could lead to fewer side effects, especially concerning swallowing, compared to the standard approach. However, there's also a chance you might experience side effects common to radiotherapy, such as soreness in the treated area or difficulty swallowing, regardless of which group you are in. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Miami Cancer Institute
    Verified postcode
    Miami, United States· Recruiting
  • London Regional Cancer Program
    Verified postcode
    London, Canada· Recruiting
  • CHUM
    Verified postcode
    Montreal, Canada· Recruiting
  • Cork University Hospital
    Unverified
    Wilton, Ireland· Recruiting
  • University Hospital Galway, Newcastle Road
    Verified postcode
    Galway, Ireland· Recruiting
  • St. Luke's Radiation Oncology Network
    Verified postcode
    Rathgar, Ireland· Recruiting
  • Beaumont St. Luke's Centre
    Verified postcode
    Dublin, Ireland· Recruiting
  • Beatson West of Scotland Cancer Centre
    Verified postcode
    Glasgow, 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?

Register your interest

Share your details and the research team for "Preservation of Swallowing in Respected Oral Cavity Squamous…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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