Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer (FIBROTHERME)

March 5, 2024 updated by: Association Francaise pour la Recherche Thermale

Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission

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 the end of postoperative radiotherapy for breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Radiation-induced fibrosis is an equivalent of an "orphan disease", in which oncologists have only recently shown interest, despite its prevalence. No study on the medical service provided by crenotherapy has been published in late radiation-induced fibrosis, which shares a common pathophysiology and medico-psycho-social sequelae with the sequelae of burns.

Chronic progressive dermatoses are part of the 12 main therapeutic orientations of medical thermalism. In particular, burn scars are a very current indication. Crenotherapy allows the attenuation, or even the disappearance of: pruritus and dysesthesia, local inflammation, hypertrophy and sclerosis and favours the recovery of chronic superficial erosions. Fibrous scars, even old ones, respond favourably to thermal treatments. The thermal treatment combines baths which have a sedative, muscle-relaxing effect and which favour 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.

The primary endpoint is the self-assessment by the patient of the dermatological quality of life by the DLQI 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).

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female
  • Age ≥ 18 years
  • In situ or invasive breast cancer
  • DLQI ≥ 6 (at least moderate effect on patient's life)
  • General status WHO 0-1
  • Post-operative radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay)
  • Unilateral breast radiotherapy
  • Skin or soft tissue toxicity (- modules: Skin and subcutaneous tissue disorders / Musculoskeletal disorders / Reproductive organs and breast disorders) 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
  • Obvious skin ulceration in the treated breast
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate spa treatment
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
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...)
Sham Comparator: Late spa treatment
The spa treatment must be carried out after the 6-month visit.
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...)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis after a dermatologically oriented spa treatment.
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generic quality of life
Time Frame: 6 months
Evaluation of the medical benefit on generic quality of life. Patient self-assessment of generic quality of life using the EQ5D-3L. EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ5D has 6 items intended to measure general health. The index score is between -0.53 and 1 where a high value indicates a good quality of life. The perceived health status is between 0 and 100 where a high value indicates good health.
6 months
Breast Cancer quality of life
Time Frame: 6 months
Evaluation of the medical benefit on quality of life in patients with breast cancer. Patient self-assessment of quality of life using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ C30 Score (Quality of Life of Cancer Patients). The EORTC QLQ-C30 has 15 domains. There is no total score. For each domain, the score is between 0 and 100 where a high score for overall health and functional dimensions represents a good quality of life; and a high score for symptomatic dimensions represents a high level of symptoms.
6 months
Senological quality of life
Time Frame: 6 months
Evaluation of the medical benefit on the quality of senological life. Patient self-assessment of breast quality of life using the specific QLQ-BR23 module (breast cancer-specific quality of life questionnaire). The QLQ-BR23 has 8 domains. There is no total score. For each domain, the rank is between 1 and 5 where a high score represents the death.
6 months
Sequelae self assessment
Time Frame: 6 months
Evaluation of the medical benefit on the self-assessment of the impact of radio induced sequelae. Self-assessment by the patient with an evaluation of the severity of the radiation-induced sequelae via the Pro-CTCAE self-questionnaire (item 25: skin dryness, item 28: itching, item 36: skin reaction to radiation, item 37: skin darkening, item 48: general pain, item 53: fatigue, item 54: anxiety, item 56: sadness, item 72: breast swelling and tenderness).
6 months
Lesions radiological assessment
Time Frame: 6 months
Hetero-evaluation of the clinical and imaging efficacy of treatment on post-radiation lesions with CTCAE scale (Common Terminology Criteria for Adverse Events). For each domain, the score is between 0 and 100 where a high score for the functional dimensions represents a good quality of life; and a high score for the symptomatic dimensions represents a high level of symptoms.
6 months
Thickness radiological assessment
Time Frame: 6 months
Hetero-evaluation of the clinical and imaging efficacy of treatment on post-radiation lesions of thickness. Imaging assessment with blinded measurement by an independent radiologist of comparative thickness by ultrasound: Dermal radiotoxicity can indeed be defined as the difference in dermal thickness between the 2 breasts (lesion area and mirror area of the contralateral breast) Dermal thickness is defined as the distance between the input ultrasound signal and the signal at the dermal-hypodermal interface at 6 months.
6 months
Volumetric aspect radiological assessment
Time Frame: 6 months
Hetero-evaluation of the clinical and imaging efficacy of treatment on post-radiation lesions with HBCS (Harvard-Breast-Cosmesis-Scale). Evaluation of the cutaneous and volumetric aspect by an evaluation carried out by the practitioner with the Harvard-breast-cosmesis-scale (HBCS) score at 6 months. The HBCS score is assessed by a 4-point Likert scale where a high value indicates a high severity, 1 represents excellent breast shape or texture, 2 means good, 3 average and 4 poor with a severely deformed breast.
6 months
Consumption of medical consultation
Time Frame: 6 months
Comparison of the number of hospitalisations, consultations, physiotherapy, specific cosmetic consultations between the 2 groups.
6 months
Adverse events
Time Frame: 6 months
Comparison of the adverse events in the 2 groups. Description of adverse events between the 2 groups.
6 months
Long-term cure quality of life benefice
Time Frame: 12 months
Evaluation of the stability of the long-term effect for the immediate cure group. Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes. Self-assessment by the patient of the dermatological quality of life by the DLQI (Dermatology Life Quality Index).
12 months
Treatment effect size
Time Frame: 12 months
Evaluation of the effect size of the treatment for the delayed treatment group. Confirmation of the size of the effect of the treatment on the primary and main secondary endpoints between 6 and 12 months.
12 months
Consumption of treatment
Time Frame: 6 months
Comparison of the type of treatment between the 2 groups.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Francaise pour la Recherche Thermale

Collaborators

Floralis

Investigators

  • Principal Investigator: Guillaume Vogin, Centre François Baclesse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A00091-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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