Can heat boost chemo? early trial tests thermotherapy for head and neck cancer

NCT ID NCT07690618

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This early-phase trial tests whether adding mild heat therapy (thermotherapy) to standard chemoradiation is safe and tolerable for people with advanced head and neck cancer. The heat, applied once a week, aims to make the cancer more sensitive to treatment. The study includes two groups: one receiving chemoradiation plus heat, and another receiving radiation alone plus heat. The main goal is to find the best heat dose and check for side effects like mouth stiffness or burns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
thermotherapy (mild hyperthermia)
What this could lead to
If successful, this could lead to a new, safe way to boost the effectiveness of standard chemoradiation for head and neck cancer, potentially reducing tumor recurrence.
What could go wrong
This is a very early phase I trial with only 30 participants, so it is primarily testing safety and dosing, not yet effectiveness. Adding heat may increase side effects like mouth stiffness, burns, or tissue damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

For eligibility to participate in this study in the primary cohort, a patient must meet all following criteria: * Age ≥ 18 years * WHO 0-1 * Maximal mouth opening of ≥ 40 mm for women and ≥ 45 mm for men before treatment * Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx proven by cytology/histology * Locally advanced disease (stage III-IV) * Curative intent treatment with radiotherapy and concurrent platinum based chemotherapy in primary setting * Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician * Written informed consent For the parallel secondary cohort, the same inclusion criteria must be met, except for the standard of care treatment: * Curative intent treatment with radiotherapy monotherapy in primary setting Exclusion criteria for either cohort: * Patients previously treated by radiation on the same target volume. * Any condition or circumstance potentially hampering compliance with the follow-up schedule.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erasmus Medical Center

    RECRUITING

    Rotterdam, South Holland, 3015 CD, Netherlands

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