RecruitingNAINTERVENTIONAL

Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality

This study is exploring a new way to treat pain when cancer has spread to the bones in your spine. Currently, radiation therapy is used to help, but this trial wants to see if we can use a more precise method, giving a smaller dose of radiation only to the affected area, while avoiding nearby healthy bones. The main aim is to check if this new, more targeted approach is just as good at relieving pain after 30 days. We also want to find out if it leads to fewer side effects and improves your overall quality of life. The study will also look at how monitoring patients remotely can help identify those who need support and care. It compares two methods of radiation to see which is best.

At a glance

Status

Recruiting

Phase

Sponsor

Institut de Cancérologie de Lorraine

Enrolment target

598

Start

02 Jul 2025

Estimated completion

02 Jan 2029

Bone Metastasis Oncology Pain

What is this study about?

When cancer spreads to the bones, especially in the spine, it can cause a lot of pain. Doctors often use a treatment called radiotherapy to help ease this pain. Radiotherapy uses high-energy rays to shrink the cancer cells and reduce the pain.

In this study, researchers are looking at ways to make this pain relief treatment even better. In the past, radiotherapy wasn't as precise, and some healthy areas around the spine might have received radiation too. However, with modern technologies like CT scans, doctors can now target the affected areas much more accurately. This study wants to see if using this precision to give a smaller dose of radiation, by carefully avoiding healthy parts of the spine, can still be very effective at reducing pain.

The study has two main groups. One group will receive the standard method of spinal radiotherapy, which might include a slightly larger area. The other group will receive the new, more targeted method where the radiation carefully avoids the healthy bones next to the painful area. By comparing these two groups, the researchers hope to find out if the more targeted approach works just as well for pain relief, but with potentially fewer side effects, ultimately improving patient comfort and well-being.

Key takeaways

This study aims to improve pain relief for cancer that has spread to the spine.
It tests a new, more precise radiotherapy method against a standard one.
The goal is better pain relief with fewer side effects.
Researchers will also look at using remote monitoring for patient care.
Participation involves receiving one of two radiotherapy treatments.
It could potentially lead to better future treatments for spinal pain.

Who may be eligible?

To join this study, you would typically be an adult patient experiencing pain because your cancer has spread to your spine. This pain needs to be at least moderate and you should either be taking pain medication for at least a week or finding them difficult to tolerate. Your doctor would have identified your bone lesions (cancer spots) using imaging scans, and you'd need to be planned for a specific type of pain-relieving radiotherapy.

There are also some other important checks. Your general health should be good enough to participate, and doctors would expect you to have a life expectancy of at least three months. You also need to be willing to follow the study plan and sign a form confirming you understand and agree to take part.

However, some people won't be able to join. This includes children, or if you're having certain other types of radiotherapy or had previous extensive radiotherapy to the same area. Also, if the spread of cancer to your spine is causing severe pressure on your spinal cord, you might not be eligible.

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.

Do I have pain from cancer that has spread to my spine?
Is my pain at least moderate (e.g., scoring 5 or more out of 10)?
Am I already taking pain medication for at least 7 days or finding it hard to cope with pain relief?
Am I having radiotherapy specifically for this pain?
Am I 18 years old or older?
Has my doctor said my general health is good enough to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive radiotherapy for your spinal pain, either the standard way or a new, more targeted way, depending on which group you're randomly assigned to. You won't have a choice in which group you are in, but both approaches aim to relieve your pain.

Throughout the study, you'll have appointments to assess your pain levels and general well-being. The main focus will be on how your pain changes 30 days after your radiotherapy. You might also be asked to use a telemonitoring system, which is a way of checking in with doctors remotely to see if you need extra support or care. The frequency of visits and specific assessments will be explained in detail by the study team, along with the total duration of your participation.

Potential risks and benefits

Taking part in this study could potentially offer you effective pain relief for your spinal pain, and the new, more targeted radiotherapy might lead to fewer side effects compared to standard treatment. However, as with all medical treatments, there are potential risks, including side effects from the radiotherapy itself, and there's no guarantee that the treatment will work for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Centre Hospitalier Universitaire de Brest
Verified postcode
Brest, France· Recruiting
Centre Henri Becquerel Rouen
Verified postcode
Rouen, France· Recruiting
Institut de cancérologie de l'Ouest (ICO)
Verified postcode
Saint-Herblain, France· Recruiting
Institut de Cancérologie de Lorraine
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting

Common questions

What is 'spinal palliation'?

It means treating pain in your spine, usually when cancer has spread there, to improve your comfort and quality of life.

What's the difference between the two types of radiation in the study?

One type is the standard way of giving radiation. The other is a newer, more precise way that tries to avoid healthy bones surrounding the painful area.

Will I know which treatment I'm getting?

No, you won't choose which treatment you get, it's decided randomly (like flipping a coin) to make the study fair. Both are aimed at helping your pain.

What is 'telemonitoring'?

It's a way for doctors to keep an eye on how you're doing remotely, like using phone calls or online forms, to see if you need any extra help or support.

How long will the study last for me?

The main part of the study focuses on your pain relief after 30 days, but the full duration of your participation will be explained by the study team.

How to find out more

Jean-Christophe JCF FAIVRE, MD.

jc.faivre@nancy.unicancer.fr +33383594072 Official trial record

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