RecruitingNAINTERVENTIONAL

Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer

This study aims to understand why some individuals with head and neck cancer experience lasting pain for months after their radiotherapy treatment. Treating head and neck cancers can lead to pain and other difficulties, affecting daily life. The study wants to see if this ongoing pain is connected to things like continued smoking or drinking, feeling down or very tired, or how it generally impacts their quality of life. Researchers will gather information from patients at two hospitals, asking them to complete questionnaires about their experiences six months after their radiotherapy. The goal is to better understand these challenges so that better support and education programmes can be created for patients in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Caen

Enrolment target

120

Start

13 Mar 2023

Estimated completion

01 Sep 2026

Neuropathic Pain Anxiety Disorder/Anxiety State Pain, Chronic Alcohol Use Disorder Psychoactive Substance Use Sleep Symptoms and Signs Addiction Nicotine

What is this study about?

When people are treated for head and neck cancers, whether it's the illness itself or the treatment like radiotherapy, it can sometimes lead to lasting problems. One common issue is pain, which can be both physical and emotional. We know that quite a few patients experience chronic pain for many months after their treatment, and this can be difficult to manage, sometimes requiring strong painkillers.

At the same time, we've noticed that some patients continue to smoke or drink alcohol after their treatment. This study wants to explore if there's a connection between this ongoing pain and continuing these habits, or if it's linked to feeling low, very tired, or generally affecting how they live their life day-to-day. Understanding these links is really important because it helps us figure out how best to support patients.

To do this, researchers at two different hospitals will follow 120 patients who are having radiotherapy for their first head and neck cancer. They will ask these patients to fill out questionnaires six months after their radiotherapy to gather information about their pain levels, habits, and how they are feeling. The study will last for about 18 months in total to enrol all the patients. The information gathered from this study will help doctors and nurses create better care plans and support services, like special education programmes, to help patients manage their symptoms and improve their quality of life after treatment.

Key takeaways

The study explores ongoing pain after head and neck cancer radiotherapy.
It checks links between pain, lifestyle habits, and well-being.
Participation involves filling out questionnaires around six months post-radiotherapy.
The goal is to improve patient support and education.
No new treatments or medications are involved in this study.

Who may be eligible?

To be considered for this study, you would need to be over 18 years old and having radiotherapy for your first head and neck cancer. Your cancer must be confirmed and stable, meaning there are no signs it has come back or spread, and you wouldn't have had radiotherapy before. You also need to be well enough generally, with a life expectancy of more than three months, and be able to speak French फ्लूently so you can complete the questionnaires.

There are certain reasons why you wouldn't be able to join. For example, if you've had other cancers in the past (unless it was a treated and cured skin or cervical cancer), or if you've had certain complex surgeries that affect swallowing or eating. You also couldn't join if you have an uncontrolled infection, a psychiatric condition that might make participating difficult, or if your cancer has shown signs of coming back or spreading.

Crucially, you must be willing and able to give your written permission to take part. The study is designed for specific circumstances to make sure the results are as clear and helpful as possible.

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 over 18 years old?
Are you having radiotherapy for your first head and neck cancer?
Have you NOT had radiotherapy before for cancer?
Is your cancer stable, with no signs of coming back or spreading?
Can you speak French fluently?
Are you willing to give your written consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement would be quite straightforward. You won't be given any new medications or treatments. Instead, the main part of your participation would involve completing questionnaires. These questionnaires will ask about your pain, any habits like smoking or drinking, how you're feeling emotionally (like anxiety or depression), if you're tired, how well you're sleeping, and your general quality of life.

You would complete these questionnaires approximately six months after you've finished your radiotherapy treatment. There are no additional hospital visits specifically for the study beyond your regular follow-up appointments. The total duration of your active involvement would be around the time it takes to complete the questionnaire. The study aims to gather this information from patients over an 18-month period, but your individual participation would be a one-off assessment.

Potential risks and benefits

Taking part in this study primarily involves answering questionnaires, so there are very few direct physical risks. You might find some questions about pain, anxiety, or addiction to be sensitive or emotionally challenging, but you can choose not to answer any questions you're uncomfortable with, and you can withdraw from the study at any time without affecting your medical care. The main benefit is that your information will help researchers understand better why some patients experience long-term pain and other issues after head and neck cancer treatment. This knowledge can lead to improved support and educational programmes for future patients, helping others in similar situations.

Locations (1)

Caen University Hospital
Verified postcode
Caen, France· Recruiting

Common questions

What is the main goal of this study?

The study aims to understand why some head and neck cancer patients have ongoing pain after radiotherapy and if it's connected to other health issues or habits.

Will I have to take any new medicines?

No, this study only involves answering questionnaires. You won't be given any new medicines or treatments.

When would I participate in the study?

You would be asked to complete questionnaires about six months after your radiotherapy treatment has finished.

Can I stop participating if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect your medical care.

How will my information be used?

Your information will help researchers create better support and education programmes for future patients with head and neck cancer.

How to find out more

Maxime Humbert, MD

humbert-m@chu-caen.fr 0231064640 Official trial record

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