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Spa treatment may ease radiation skin damage in cancer survivors

NCT ID NCT05874492

Symptom relief Sponsor: Association Francaise pour la Recherche Thermale Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special spa therapy can improve skin-related quality of life in people who have skin hardening (fibrosis) after radiation for breast or head/neck cancer. About 110 adults who finished radiation at least 6 months ago will be randomly assigned to receive spa therapy right away or after a 6-month wait. The main goal is to see if the treatment reduces skin discomfort and improves daily life.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

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

Started

Jan 2024

Expected to finish

Dec 2027

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.

Inclusion Criteria: * Age ≥ 18 years * In situ or invasive breast cancer or cancer of the upper aerodigestive tract * DLQI ≥ 6 (at least moderate effect on patient's life) * General status WHO 0-1 * Radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay) * Unilateral breast radiotherapy for breast cancer patients * Skin or soft tissue toxicity (- modules: Skin atrophy, fibrosis of deep connective tissues, fibrosis of superficial soft tissues) CTCAE v4.0 grade ≥ 2 * No inflammatory or infectious flare at inclusion * Female of childbearing potential: negative urine pregnancy test at inclusion * Patient informed and signed consent * Affiliation to a social security systeme or equivalent Exclusion Criteria: * Progressive phase of cancer * Metastatic disease * Patient undergoing specific treatment for breast cancer (except adjuvant hormone therapy and/or adjuvant herceptin) * Bilateral breast/parietal radiotherapy * Breast prosthesis wearer for breast cancer patients * Patient with a tracheostomy for patients with head and neck cancer * Obvious skin ulceration in the site of interest * Contraindication to spa treatment (acute inflammatory disease, active infections, heart failure with NYHA stage \> 1, chronic respiratory failure, labile hypertension, bullous disease) * Chronic progressive dermatological disease * Women who are pregnant or likely to become pregnant within 6 months or who are breastfeeding * Persons deprived of liberty or under guardianship

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Fibrosis head and neck cancer Head and Neck Neoplasms upper aerodigestive tract neoplasm

As listed by the trial registrant

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

Breast cancer Fibrosis Head and neck cancer

How to take part

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

  1. The places running it

    13 sites in 2 countries. 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.

    Open the record ↗

  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

  • CHU Saint Etienne

    RECRUITING

    Saint-Etienne, France

  • Centre Azuréen de Cancérologie

    RECRUITING

    Mougins, France

  • Centre Eugène Marquis

    RECRUITING

    Rennes, 35000, France

  • Centre François Baclesse

    NOT_YET_RECRUITING

    Esch-sur-Alzette, L-4240, Luxembourg

  • Centre Hospitalier Intercommunal Créteil

    RECRUITING

    Créteil, 94000, France

  • Centre Hospitalier Roanne

    RECRUITING

    Roanne, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    RECRUITING

    Grenoble, 38000, France

  • Clinique Tivoli-Ducos

    RECRUITING

    Bordeaux, 33000, France

  • Groupe Hospitalier Mutualiste de Grenoble

    RECRUITING

    Grenoble, 38000, France

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, 13009, France

  • Institut Rafael

    RECRUITING

    Levallois-Perret, France

  • Institut de Cancérologie de Bourgogne

    RECRUITING

    Dijon, 21000, France

  • Institut de Cancérologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

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