RecruitingNAINTERVENTIONAL

Thermotherapy in Addition to SOC Palliative Radiotherapy

This study is exploring a new way to treat certain advanced or recurrent cancers: head and neck squamous cell carcinoma, skin (cutaneous) squamous cell carcinoma, and recurrent breast cancer. It combines standard palliative radiotherapy (radiation treatment to relieve symptoms) with a gentle heat treatment called superficial hyperthermia. This heat therapy uses a special machine to warm the tumour and surrounding area. The goal is to see if adding heat makes the radiotherapy work better and helps to shrink the tumours more effectively. This study is for patients whose cancer can't be cured with surgery or other radical treatments and who have suitable superficial tumours.

At a glance

Status

Recruiting

Phase

Sponsor

King's College London

Enrolment target

Start

14 Oct 2024

Estimated completion

01 Mar 2028

Head and Neck Squamous Cell Carcinoma Cutaneous Squamous Cell Carcinoma Breast Cancer Recurrent

What is this study about?

This study is looking at a new way to treat certain advanced or recurring cancers using a combination of treatments. The main idea is to add a gentle heat treatment, called thermotherapy or hyperthermia, to the standard radiotherapy that patients usually receive. Radiotherapy uses radiation to target and kill cancer cells. The special heat treatment warms up the tumour and the area around it using a machine that focuses gentle infra-red heat. The purpose of the heat is to make the cancer cells more sensitive to the radiotherapy, hopefully helping the treatment work better.

Heat treatment has been shown in other countries to help make cancer cells more vulnerable to treatments like radiotherapy. This is the first time this specific heat treatment machine is being used in a study in the UK. The researchers want to understand how well this combined approach works in a real-world setting for patients with specific types of advanced head, neck, skin, or recurrent breast cancers that cannot be fully removed by surgery or treated radically in other ways. The main goal is to see if adding this heat treatment improves the chances of the tumours shrinking.

The study will involve patients with locally advanced or recurrent head and neck squamous cell carcinoma, cutaneous (skin) squamous cell carcinoma in the head and neck region, or locally recurrent breast cancer. This is for patients who have superficial (close to the skin surface) tumours that are suitable for this gentle heat treatment and are receiving radiotherapy to help manage their symptoms or control the cancer.

Key takeaways

This study combines heat treatment (thermotherapy) with standard radiotherapy.
It's for specific types of advanced or recurrent head, neck, skin, and breast cancers.
The heat treatment aims to make radiotherapy work better on cancer cells.
This is the first time this specific heat treatment is being used in a UK study.
The goal is to see if this combined treatment is safe and effectively shrinks tumours.
It's for patients whose cancer cannot be cured with surgery or other radical treatments.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) with cancer that has been confirmed by a doctor, and it must be a type that cannot be cured with surgery or other aggressive treatments. Importantly, you need to have at least one tumour on the surface of your body or a lymph node that can be reached by the gentle heat treatment machine used in this study. You also need to be receiving standard radiotherapy for your cancer, and it must be at a dose specified by the study.

There are also some general health requirements, meaning you should be reasonably well and able to consent to take part in the study. Your doctor will assess your overall health using a scale called ECOG, and you would need to be rated 0 or 1, which means you can mostly look after yourself and are up and about.

You would not be able to join the study if you don't have a tumour that can be treated by the heat machine, or if the planned radiotherapy doesn't match the study’s requirements. Similarly, if you have certain mental health conditions or substance abuse issues that would make it difficult to follow the study's instructions, you wouldn't be able to participate.

Quick self-check

Are you 18 years old or older?
Do you have advanced or recurrent head, neck squamous cell, cutaneous squamous cell, or recurrent breast cancer?
Do you have a tumour close to the skin surface that could be treated with heat?
Are you currently undergoing or scheduled for palliative radiotherapy?
Are you generally well enough to participate in a study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The description for participation is not provided in the original text, therefore, this section cannot be filled.

Potential risks and benefits

Potential benefits of taking part in this study could include the possibility that the combined heat and radiotherapy treatment might be more effective at shrinking your tumours than radiotherapy alone, potentially improving your symptoms or local control of your cancer. However, this is not guaranteed, as the study is designed to investigate this. Potential risks related to the heat treatment could include warmth or discomfort in the treated area, and your medical team will monitor you closely. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Guy's and St. Thomas NHS Foundation Trust
London, United Kingdom· Recruiting
Guy's Cancer Centre
London, United Kingdom· Recruiting

Common questions

What is thermotherapy?

Thermotherapy is a gentle heat treatment that warms up cancer cells, aiming to make them more sensitive to other treatments like radiotherapy.

Which cancers are being studied?

This study is for certain advanced or recurrent head and neck squamous cell cancer, skin (cutaneous) squamous cell cancer, and recurrent breast cancer.

Is this heat treatment available in the UK already?

No, this specific heat treatment machine is new to the UK and this centre is the first to use it in a study.

What is the main goal of the study?

The main goal is to see how safe and effective adding this heat treatment to regular radiotherapy is for shrinking specific types of tumours.

Who can consider joining?

Adults with certain advanced or recurrent cancers that have visible (superficial) tumours suitable for the heat treatment, and who are receiving standard radiotherapy.

How to find out more

Anthony Kong

Anthony.Kong@kcl.ac.uk 44+2078486004 Official trial record

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