RecruitingNot ApplicableNCT05874492

Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer

Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer in Remission


Sponsor

Association Francaise pour la Recherche Thermale

Enrollment

110 participants

Start Date

Jan 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

FIBROTHERME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial. The aim of this study is to evaluate the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis 6 months after a dermatologically oriented spa therapy in patients with severe late reactions affecting the skin and/or soft tissues at least 6 months after radiotherapy for breast cancer or UADT (Upper Aerodigestive Tract) cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether spa (hydrotherapy) treatment can help women who have developed skin tightening or tissue damage (fibrosis) after radiation therapy for breast cancer. The goal is to see if spa therapy improves quality of life and reduces discomfort. **You may be eligible if...** - You are a woman aged 18 or older - You had surgery and radiation therapy for breast cancer (in situ or invasive), completed at least 6 months ago - You have at least moderate skin or soft tissue side effects from radiation (Grade 2 or higher) - Your cancer is not currently active or spreading - Your daily life is moderately affected by your skin condition (DLQI score of 6 or higher) **You may NOT be eligible if...** - Your cancer is currently progressing or has spread (metastatic) - You are still receiving active cancer treatment (other than hormone therapy or Herceptin) - You had radiation to both breasts or chest wall - You have a breast implant - You have an open wound or skin ulcer at the treated breast - You are pregnant or planning pregnancy within 6 months - You have heart failure, active infection, or other conditions that prevent spa treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERThermal cure with a primary dermatological indication

The thermal treatment combines baths which have a sedative, muscle-relaxing effect and encourage joint mobilisation, sprays which have a decongestant effect and, above all, thread-like showers which are carried out by jets of thermal water under high pressure for several minutes plus educational workshops (relaxation, sophrology, hygiene...)


Locations(13)

Clinique Tivoli-Ducos

Bordeaux, France

Centre Hospitalier Intercommunal Créteil

Créteil, France

Institut de Cancérologie de Bourgogne

Dijon, France

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, France

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, France

Institut Rafael

Levallois-Perret, France

Institut Paoli-Calmettes

Marseille, France

Centre Azuréen de Cancérologie

Mougins, France

Centre Eugène Marquis

Rennes, France

Centre Hospitalier Roanne

Roanne, France

CHU Saint Etienne

Saint-Etienne, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Centre François Baclesse

Esch-sur-Alzette, Luxembourg

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NCT05874492


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