RecruitingNAINTERVENTIONAL

Phase II Study of Daily Adaptive Radiotherapy for Submandibular Gland-sparing in Head and Neck Cancer

This research is looking into a type of head and neck cancer called Squamous Cell Cancer. The study is comparing two ways of giving radiation therapy: the usual method and a newer, 'daily adaptive' method. The main goal is to see if this daily adaptive treatment can better protect a gland in your neck called the submandibular gland, which produces saliva (spit). Protecting this gland could help reduce dry mouth, a common side effect of radiation therapy. Researchers will measure how well the gland works and ask patients about their quality of life after treatment. Fifty patients are expected to take part in this study.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

15 Oct 2025

Estimated completion

01 Oct 2029

Squamous Cell Cancer of Head and Neck (SCCHN)

What is this study about?

Imagine you have head and neck cancer, and your doctors recommend radiation therapy. This treatment uses strong X-rays to kill cancer cells. While it's very effective at treating cancer, sometimes these X-rays can also affect nearby healthy parts of your body, like the glands that make spit. When these glands are damaged, it can lead to a very uncomfortable side effect called dry mouth.

This study is looking at a new way to give radiation therapy called 'daily adaptive radiotherapy' (ART). Think of it like this: your body can change slightly from day to day, for example, if you've lost a bit of weight. Standard radiation plans are usually set for the whole treatment based on initial scans. Daily ART, however, involves taking a quick scan each day before treatment and adjusting the radiation plan slightly if needed. This allows the medical team to be more precise and potentially avoid healthy areas, like your spit glands, more effectively.

The main aim of this research is to see if this daily adaptive approach can be better at protecting the submandibular gland, one of the main glands that produces spit, compared to the standard radiation treatment. Researchers want to know if this more tailored approach can reduce dry mouth and overall improve your comfort and quality of life during and after cancer treatment.

Key takeaways

Compares two radiation treatments for head and neck cancer.
Aims to reduce dry mouth by protecting spit glands.
Treatment lasts about 7 weeks, with follow-up appointments.
You won't know which treatment group you're in.
Participation is voluntary and you can leave at any time.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have a specific type of head and neck cancer called Squamous Cell Carcinoma. Your doctors must have decided that you would benefit from a cure-focused treatment that involves radiation, possibly along with chemotherapy. Importantly, the part of your cancer being treated shouldn't be too close to one of your spit glands, specifically the submandibular gland, which this study aims to protect.

You also need to be generally well enough to undergo the treatment, as judged by a medical score called ECOG Performance Status (a score of 0-2 means you're pretty active). You must be able to understand what the study involves and be willing to give your written consent to participate. It's also important that you can lie comfortably on your back for up to an hour at a time during treatment, wearing a special mask to keep still.

There are also reasons why you might not be able to join. For example, if you have other serious health problems that your doctor thinks would make the study unsafe for you, or if you are pregnant. Also, if you already have significant problems with your spit glands before treatment, you might not be eligible, as it could make it hard to see if the new treatment has any specific benefit for gland protection.

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 or older?
Do you have Squamous Cell Cancer of the head and neck?
Are you able to lie still on your back for up to an hour?
Are you planned to have radiation therapy with a goal to cure your cancer?
Are you NOT pregnant and do you NOT have existing severe problems with your spit glands?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups: either you'll receive the standard radiation therapy, or you'll receive the new daily adaptive radiation therapy. You won't know which group you're in, to help ensure an unbiased assessment of your quality of life during the study. Before treatment starts, you'll have several checks, including detailed scans, dental assessments, a swallowing assessment, a test to measure your spit flow, and you'll fill out questionnaires about your quality of life.

The radiation treatment itself will take about 7 weeks to complete. After your treatment has finished, you'll have follow-up visits to check on your health and any side effects. These visits will happen at about 1.5 months, 6 months, 12 months, and 24 months after your treatment ends. At each of these follow-up appointments, you'll have similar assessments to the ones you had at the beginning, like spit flow tests and quality of life questionnaires, to see how you're doing over time.

Potential risks and benefits

Participating in this study might offer a potential benefit if you receive the daily adaptive radiation therapy, as it aims to reduce the risk of dry mouth, a common side effect of head and neck cancer treatment, which could improve your comfort and quality of life. Even if you receive the standard treatment, you'll be closely monitored, and your information will help improve care for future patients. All medical treatments carry risks, and side effects from radiation therapy are possible in both groups. You will be fully informed of all known risks associated with each treatment approach before you agree to participate. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'daily adaptive radiotherapy'?

It's a newer radiation treatment that scans you every day and adjusts the plan slightly if needed, aiming to be more precise and protect healthy body parts better.

Why is protecting the 'submandibular gland' important?

This gland produces spit (saliva). Protecting it can help prevent dry mouth, a common and uncomfortable side effect of radiation therapy.

Will I know which treatment I'm getting?

No, you won't know if you're getting the standard or the new adaptive therapy. This helps make sure everyone's feedback is unbiased.

How long will the treatment last?

The radiation treatment itself will last for approximately 7 weeks.

What kind of cancer is this study for?

This study is for Squamous Cell Cancer of the head and neck.

How to find out more

Andrew McPartlin, MD

andrew.mcpartlin@uhn.ca 416-946-2132 Official trial record

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