Trial Title:
Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer
NCT ID:
NCT05874492
Condition:
Fibrosis
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Fibrosis
Dermatologic Agents
Conditions: Keywords:
fibrosis
breast cancer
radiotherapy
spa treatment
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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
Primary purpose:
Other
Masking:
Single (Investigator)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
Thermal cure with a primary dermatological indication
Description:
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...)
Arm group label:
Immediate spa treatment
Arm group label:
Late spa treatment
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 the end of postoperative radiotherapy for breast 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).
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique Tivoli-Ducos
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Contact:
Last name:
Christophe Debelleix
Email:
christophedebelleix@yahoo.fr
Facility:
Name:
Institut de Cancérologie de Bourgogne
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Benjamin Schipman
Email:
benschipman@yahoo.fr
Facility:
Name:
Groupe Hospitalier Mutualiste de Grenoble
Address:
City:
Grenoble
Zip:
38000
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie-Virginie Claeys
Email:
mv.claeys@ghm-grenoble.fr
Facility:
Name:
Centre de cancérologie de la Sarthe
Address:
City:
Le Mans
Zip:
72000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Yoann Pointreau
Email:
pointr_y@yahoo.fr
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69973
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Séverine Racadot
Email:
severine.racadot@lyon.unicancer.fr
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Contact:
Last name:
Mohamed Benchalal
Email:
m.benchalal@rennes.unicancer.fr
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54519
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Selima Sellami
Email:
s.sellami@nancy.unicancer.fr
Facility:
Name:
Centre François Baclesse
Address:
City:
Esch-sur-Alzette
Zip:
L-4240
Country:
Luxembourg
Status:
Not yet recruiting
Contact:
Last name:
Guillaume Vogin
Email:
guillaume.vogin@baclesse.lu
Start date:
January 29, 2024
Completion date:
April 2026
Lead sponsor:
Agency:
Association Francaise pour la Recherche Thermale
Agency class:
Other
Collaborator:
Agency:
Floralis
Agency class:
Industry
Source:
Association Francaise pour la Recherche Thermale
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05874492
https://www.ligue-cancer.net/sites/default/files/rapport-2013-observatoire-societal-des-cancers.pdf
