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

NCT05874492 | Recruiting

• 1 other identifier: 2023-A00091-44
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 13

Brief 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

Fibrosis; Breast Cancer; Head and Neck Cancer

Keywords

fibrosis; breast cancer; radiotherapy; spa treatment; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis after a dermatologically oriented spa treatment.

  Self-assessment by the patient of the dermatological quality of life by the DLQI (Dermatology Life Quality Index) score at 6 months after the end of the treatment compared between the intervention group (immediate treatment) and the control group (delayed treatment after 6 months). The DLQI score is between 0 and 30 where a high score indicates a significant impairment of quality of life.

  6 months

Secondary Outcomes (13)

• Generic quality of life

  6 months

• Cancer quality of life

  6 months

• Senological or Upper Aerodigestive Tract (UADT) Cancer quality of life

  6 months

• Sequelae self assessment

  6 months

• Lesions radiological assessment

  6 months

Study Arms (2)

Immediate spa treatment

ACTIVE COMPARATOR

The spa treatment must be carried out within a maximum of 6 weeks after the inclusion visit.

Other: Thermal cure with a primary dermatological indication

Late spa treatment

SHAM COMPARATOR

The spa treatment must be carried out after the 6-month visit.

Other: Thermal cure with a primary dermatological indication

Interventions

Thermal cure with a primary dermatological indication OTHER

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...)

Immediate spa treatment; Late spa treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient informed and signed consent
• Affiliation to a social security systeme or equivalent

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead
• Floralis: collaborator

Study Sites (13)

Clinique Tivoli-Ducos

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier Intercommunal Créteil

Créteil, 94000, France

RECRUITING

Institut de Cancérologie de Bourgogne

Dijon, 21000, France

RECRUITING

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38000, France

RECRUITING

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38000, France

RECRUITING

Institut Rafael

Levallois-Perret, France

RECRUITING

Institut Paoli-Calmettes

Marseille, 13009, France

RECRUITING

Centre Azuréen de Cancérologie

Mougins, France

RECRUITING

Centre Eugène Marquis

Rennes, 35000, France

RECRUITING

Centre Hospitalier Roanne

Roanne, France

RECRUITING

CHU Saint Etienne

Saint-Etienne, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

Centre François Baclesse

Esch-sur-Alzette, L-4240, Luxembourg

NOT YET RECRUITING

Related Publications (17)

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  PMID: 20888056 BACKGROUND

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  PMID: 33886127 BACKGROUND

• Offersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Krause M, Stenbygaard L, Mjaaland I, Schreiber A, Kasti UM, Overgaard J; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial. J Clin Oncol. 2020 Nov 1;38(31):3615-3625. doi: 10.1200/JCO.20.01363. Epub 2020 Sep 10.

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Related Links

• Rapport 2013 de l'Observatoire sociétal des cancers. 2014.

MeSH Terms

Conditions

Fibrosis; Breast Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Guillaume Vogin

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nans FUSTIER

CONTACT

0476765040; nans.fustier@univ-grenoble-alpes.fr

Claire Eychenne

CONTACT

0476766413; claire.eychenne@univ-grenoble-alpes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomisation will be carried out by the coordinating centre by telephone. This methodology will maintain the investigator's blindness, the coordinating centre will ask the patient not to talk to the investigator about her treatment during follow-up visits.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups: * Immediate spa therapy: the patient carries out the spa therapy soon after the enrolment in the study * Late spa therapy: the patient carries out the spa therapy after the 6-month follow up visit

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 25, 2023
• Study Start: January 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1); FR (12)