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

NCT05874492 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Thermal 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...)

Sponsors & Collaborators

  • Floralis

    collaborator INDUSTRY
  • Association Francaise pour la Recherche Thermale

    lead OTHER

Principal Investigators

  • Guillaume Vogin · Centre François Baclesse

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • France
  • Luxembourg

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05874492 on ClinicalTrials.gov