FibrosisFIBROTHERMENCT05874492
Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer
A study testing Thermal cure with a primary dermatological indication in people with Fibrosis and Breast Cancer, run by Association Francaise pour la Recherche Thermale at 13 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrosis, Breast Cancer, Head and Neck Cancer
- What is being tested?
- Thermal cure with a primary dermatological indication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 29 Jan 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
France12 sites, 12 recruiting
- Recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
Christophe Debelleix, christophedebelleix@yahoo.fr
- Recruiting
Centre Hospitalier Intercommunal Créteil
Créteil, 94000
Soumya ANANE, Soumya.Anane@chicreteil.fr
- Recruiting
Institut de Cancérologie de Bourgogne
Dijon, 21000
Benjamin Schipman, benschipman@yahoo.fr
- Recruiting
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38000
Pauline KORDALSKI, PKordalski@chu-grenoble.fr
- Recruiting
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38000
Marie-Virginie Claeys, mv.claeys@ghm-grenoble.fr
- Recruiting
Institut Rafael
Levallois-Perret
Alain TOLEDANO, 01 82 64 97 28, alain.toledano@gmail.com
- Recruiting
Institut Paoli-Calmettes
Marseille, 13009
Agnès TALLET, RICHARDA@ipc.unicancer.fr
- Recruiting
Centre Azuréen de Cancérologie
Mougins
Alexander FALK, 04 92 92 37 37, A.Falk@cac-mougins.fr
- Recruiting
Centre Eugène Marquis
Rennes, 35000
Mohamed Benchalal, m.benchalal@rennes.unicancer.fr
- Recruiting
Centre Hospitalier Roanne
Roanne
Amel BLANCHARD, 04 77 91 74 87, Amel.BLANCHARD@ch-roanne.fr
- Recruiting
CHU Saint Etienne
Saint-Etienne
Aurélie BENETON, 04 77 82 24 41, aurelie.beneton@chu-st-etienne.fr
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Selima Sellami, s.sellami@nancy.unicancer.fr
Luxembourg1 site, 1 recruiting
- Not yet recruiting
Centre François Baclesse
Esch-sur-Alzette, L-4240
Guillaume Vogin, guillaume.vogin@baclesse.lu
About this study
Official title: 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
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.
Read the 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).
- Conditions
- Fibrosis, Breast Cancer, Head and Neck Cancer
- Being tested
- Thermal cure with a primary dermatological indication
- Keywords
- fibrosis, breast cancer, radiotherapy, spa treatment, head and neck cancer
- Medical subject headings
- Fibrosis, Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal cure with a primary dermatological indicationOther
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...)
| Study group | Role | What they receive |
|---|---|---|
| Immediate spa treatment | Active comparator | The spa treatment must be carried out within a maximum of 6 weeks after the inclusion visit. Receives: 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. Receives: Other: Thermal cure with a primary dermatological indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (13)
Generic quality of life
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.
Measured: 6 months
Cancer quality of life
Evaluation of the medical benefit on quality of life in patients with breast cancer or Upper Aerodigestive Tract (UADT) 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.
Measured: 6 months
Senological or Upper Aerodigestive Tract (UADT) Cancer quality of life
Evaluation of the medical benefit on the quality of senological life or Upper Aerodigestive Tract (UADT) Cancer. Patient self-assessment of breast quality of life using the specific QLQ-BR23 module (breast cancer-specific quality of life questionnaire).
Patient self-assessment of Upper Aerodigestive Tract (UADT) Cancer quality of life using the specific QLQ-H\&N43 module (Quality of life in patients with head and neck cancer).
Measured: 6 months
Sequelae self assessment
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 1: dry mouth, Item 2: difficulty swallowing, Item 3: mouth/throat sores, Item 4: cracked corners of the mouth, Item 5: changes in voice quality, Item 6: hoarseness, Item 7: changes in taste (Items 1-7 specific to head and neck cancer), 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 (item 72 specific to breast cancer)).
Measured: 6 months
Lesions radiological assessment
Hetero-evaluation of the clinical and imaging efficacy of treatment on post-radiation lesions with CTCAE scale (Common Terminology Criteria for Adverse Events). There is no total score. For each domain, the rank is between 1 and 5 where a high score represents the death.
Measured: 6 months
Thickness radiological assessment
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 for breast cancer can indeed be defined as the difference in dermal thickness between the 2 breasts (lesion area and mirror area of the contralateral breast). Cutaneous radiotoxicity in head and neck cancers will be assessed by comparing irradiated areas with unexposed control areas.
Dermal thickness is defined as the distance between the input ultrasound signal and the signal at the dermal-hypodermal interface at 6 months.
Measured: 6 months
Volumetric aspect radiological assessment
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.
Measured: 6 months
Consumption of treatment
Comparison of the type of treatment between the 2 groups.
Measured: 6 months
Consumption of medical consultation
Comparison of the number of hospitalisations, consultations, physiotherapy, specific cosmetic consultations between the 2 groups.
Measured: 6 months
Adverse events
Comparison of the adverse events in the 2 groups. Description of adverse events between the 2 groups.
Measured: 6 months
Long-term cure quality of life benefice
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).
Measured: 12 months
Treatment effect size
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.
Measured: 12 months
Subgroup analysis of the primary outcome
Stratification based on the location of the treated site (following breast cancer or cancer of the upper aerodigestive tract). Stratification by center to test for a center effect.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start29 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Collaborators
- Floralis
- Responsible party
- Sponsor
- Investigators
- Guillaume Vogin, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874492
- Sponsor's protocol ID
- 2023-A00091-44
- Acronym
- FIBROTHERME
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Binder-Foucard F, Bossard N, Delafosse P, Belot A, Woronoff AS, Remontet L; French network of cancer registries (Francim). Cancer incidence and mortality in France over the 1980-2012 period: solid tumors. Rev Epidemiol Sante Publique. 2014 Apr;62(2):95-108. doi: 10.1016/j.respe.2013.11.073. Epub 2014 Mar 7.
PubMed 24613140Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
PubMed 16360786Mohanti BK, Bansal M. Late sequelae of radiotherapy in adults. Support Care Cancer. 2005 Oct;13(10):775-80. doi: 10.1007/s00520-004-0697-z. Epub 2005 Jul 22.
PubMed 16041503Burnet NG, Johansen J, Turesson I, Nyman J, Peacock JH. Describing patients' normal tissue reactions: concerning the possibility of individualising radiotherapy dose prescriptions based on potential predictive assays of normal tissue radiosensitivity. Steering Committee of the BioMed2 European Union Concerted Action Programme on the Development of Predictive Tests of Normal Tissue Response to Radiation Therapy. Int J Cancer. 1998 Dec 18;79(6):606-13. doi: 10.1002/(sici)1097-0215(19981218)79:63.0.co;2-y.
PubMed 9842969Johansson S, Svensson H, Denekamp J. Timescale of evolution of late radiation injury after postoperative radiotherapy of breast cancer patients. Int J Radiat Oncol Biol Phys. 2000 Oct 1;48(3):745-50. doi: 10.1016/s0360-3016(00)00674-x.
PubMed 11020571Sarin R, Dinshaw KA, Shrivastava SK, Sharma V, Deore SM. Therapeutic factors influencing the cosmetic outcome and late complications in the conservative management of early breast cancer. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):285-92. doi: 10.1016/0360-3016(93)90239-r.
PubMed 8407402Safwat A, Bentzen SM, Turesson I, Hendry JH. Deterministic rather than stochastic factors explain most of the variation in the expression of skin telangiectasia after radiotherapy. Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):198-204. doi: 10.1016/s0360-3016(01)02690-6.
PubMed 11777639Foray N, Verrelle P. [DNA repair and repair diseases: between molecular models and clinical reality]. Bull Cancer. 2011 Mar;98(3):257-75. doi: 10.1684/bdc.2011.1326. French.
PubMed 21454154Yarnold J, Brotons MC. Pathogenetic mechanisms in radiation fibrosis. Radiother Oncol. 2010 Oct;97(1):149-61. doi: 10.1016/j.radonc.2010.09.002. Epub 2010 Sep 29.
PubMed 20888056Ly CL, Khetpal S, Heller DR, Higgins SA, Killelea B, Alperovich M, Avraham T. Comparing complications in irradiated and non-irradiated free-flaps in patients with bilateral immediate breast reconstruction and unilateral post-mastectomy radiotherapy. Microsurgery. 2021 Oct;41(7):615-621. doi: 10.1002/micr.30747. Epub 2021 Apr 22.
PubMed 33886127Offersen 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.
PubMed 32910709Delanian S, Lefaix JL. Current management for late normal tissue injury: radiation-induced fibrosis and necrosis. Semin Radiat Oncol. 2007 Apr;17(2):99-107. doi: 10.1016/j.semradonc.2006.11.006.
PubMed 17395040Jacobson G, Bhatia S, Smith BJ, Button AM, Bodeker K, Buatti J. Randomized trial of pentoxifylline and vitamin E vs standard follow-up after breast irradiation to prevent breast fibrosis, evaluated by tissue compliance meter. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):604-8. doi: 10.1016/j.ijrobp.2012.06.042. Epub 2012 Jul 28.
PubMed 22846413Wong RK, Bensadoun RJ, Boers-Doets CB, Bryce J, Chan A, Epstein JB, Eaby-Sandy B, Lacouture ME. Clinical practice guidelines for the prevention and treatment of acute and late radiation reactions from the MASCC Skin Toxicity Study Group. Support Care Cancer. 2013 Oct;21(10):2933-48. doi: 10.1007/s00520-013-1896-2. Epub 2013 Aug 14.
PubMed 23942595Carl UM, Feldmeier JJ, Schmitt G, Hartmann KA. Hyperbaric oxygen therapy for late sequelae in women receiving radiation after breast-conserving surgery. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):1029-31. doi: 10.1016/s0360-3016(00)01515-7.
PubMed 11240244
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05874492
- Acronym / sponsor ID
- FIBROTHERME / 2023-A00091-44
- Conditions
- Fibrosis, Breast Cancer, Head and Neck Cancer
- Keywords
- fibrosis, breast cancer, radiotherapy, spa treatment, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Collaborators
- Floralis
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Immediate spa treatment | Active comparator | Other: Thermal cure with a primary dermatological indicationThe spa treatment must be carried out within a maximum of 6 weeks after the inclusion visit. |
| Late spa treatment | Sham comparator | Other: Thermal cure with a primary dermatological indicationThe spa treatment must be carried out after the 6-month visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal cure with a primary dermatological indicationThe 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...) | Other | Immediate spa treatment, Late spa treatment |
Primary outcome
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.
13 secondary outcomes
Generic quality of life
Time frame: 6 months
Cancer quality of life
Time frame: 6 months
Senological or Upper Aerodigestive Tract (UADT) Cancer quality of life
Time frame: 6 months
Sequelae self assessment
Time frame: 6 months
Lesions radiological assessment
Time frame: 6 months
Thickness radiological assessment
Time frame: 6 months
Volumetric aspect radiological assessment
Time frame: 6 months
Consumption of treatment
Time frame: 6 months
Consumption of medical consultation
Time frame: 6 months
Adverse events
Time frame: 6 months
Long-term cure quality of life benefice
Time frame: 12 months
Treatment effect size
Time frame: 12 months
Subgroup analysis of the primary outcome
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 24613140Binder-Foucard F, Bossard N, Delafosse P, Belot A, Woronoff AS, Remontet L; French network of cancer registries (Francim). Cancer incidence and mortality in France over the 1980-2012 period: solid tumors. Rev Epidemiol Sante Publique. 2014 Apr;62(2):95-108. doi: 10.1016/j.respe.2013.11.073. Epub 2014 Mar 7.
- Background: PubMed 16360786Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
- Background: PubMed 16041503Mohanti BK, Bansal M. Late sequelae of radiotherapy in adults. Support Care Cancer. 2005 Oct;13(10):775-80. doi: 10.1007/s00520-004-0697-z. Epub 2005 Jul 22.
- Background: PubMed 9842969Burnet NG, Johansen J, Turesson I, Nyman J, Peacock JH. Describing patients' normal tissue reactions: concerning the possibility of individualising radiotherapy dose prescriptions based on potential predictive assays of normal tissue radiosensitivity. Steering Committee of the BioMed2 European Union Concerted Action Programme on the Development of Predictive Tests of Normal Tissue Response to Radiation Therapy. Int J Cancer. 1998 Dec 18;79(6):606-13. doi: 10.1002/(sici)1097-0215(19981218)79:63.0.co;2-y.
- Background: PubMed 11020571Johansson S, Svensson H, Denekamp J. Timescale of evolution of late radiation injury after postoperative radiotherapy of breast cancer patients. Int J Radiat Oncol Biol Phys. 2000 Oct 1;48(3):745-50. doi: 10.1016/s0360-3016(00)00674-x.
- Background: PubMed 8407402Sarin R, Dinshaw KA, Shrivastava SK, Sharma V, Deore SM. Therapeutic factors influencing the cosmetic outcome and late complications in the conservative management of early breast cancer. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):285-92. doi: 10.1016/0360-3016(93)90239-r.
- Background: PubMed 11777639Safwat A, Bentzen SM, Turesson I, Hendry JH. Deterministic rather than stochastic factors explain most of the variation in the expression of skin telangiectasia after radiotherapy. Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):198-204. doi: 10.1016/s0360-3016(01)02690-6.
- Background: PubMed 21454154Foray N, Verrelle P. [DNA repair and repair diseases: between molecular models and clinical reality]. Bull Cancer. 2011 Mar;98(3):257-75. doi: 10.1684/bdc.2011.1326. French.
- Background: PubMed 20888056Yarnold J, Brotons MC. Pathogenetic mechanisms in radiation fibrosis. Radiother Oncol. 2010 Oct;97(1):149-61. doi: 10.1016/j.radonc.2010.09.002. Epub 2010 Sep 29.
- Background: PubMed 33886127Ly CL, Khetpal S, Heller DR, Higgins SA, Killelea B, Alperovich M, Avraham T. Comparing complications in irradiated and non-irradiated free-flaps in patients with bilateral immediate breast reconstruction and unilateral post-mastectomy radiotherapy. Microsurgery. 2021 Oct;41(7):615-621. doi: 10.1002/micr.30747. Epub 2021 Apr 22.
- Background: PubMed 32910709Offersen 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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- Rapport 2013 de l'Observatoire sociétal des cancers. 2014.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Vogin principal investigator
Centre François Baclesse
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal cure with a primary dermatological indication in people with Fibrosis and Breast Cancer, run by Association Francaise pour la Recherche Thermale at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nans FUSTIER (0476765040, nans.fustier@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05874492, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.