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| Name | Class |
|---|---|
| Association Francaise pour la Recherche Thermale | OTHER |
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This study evaluates the dermatological life quality six months after spa cares in patients with severe late toxicity involving the skin and / or soft tissues after postoperative radiotherapy for breast cancer. Half of the patients will be treated with a combination of pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive skin-oriented spa cares in addition.
The combination of PTX and vit E appears as the standard treatment of radiation induced fibrosis. Synergism between PTX and Vit E is likely, as treatment with each drug alone is ineffective. This combination was also positively evaluated in the treatment of osteoradionecrosis, radiation-induced pelvic neuropathies, pneumoniae as well as bowel pathologies.
Spa cares are part of the standard treatment of burn scars. Two spa treatments per year enable the mitigation or disappearance (after several treatments) of pruritus, dysesthesia, local inflammation, hypertrophy and sclerosis. They promote the healing of chronic superficial erosions. The spa treatment combines baths, sprays and especially filiform showers with thermal water jets under high pressure for a few minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination tocopherol/pentoxifylline + spa care | Experimental | pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days) |
|
| combination tocopherol/pentoxifylline | Active Comparator | pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skin-oriented spa care | Other | standardized procedure : 72 care sessions over 18 days of treatment +/- Additional care according to the specificity of each spa |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dermatology Quality of life at 6 months | Self-reported dermatology quality of life using the standardized Dermatology Life Quality Index (DLQI) ; This score assess the functional impact of fibrosis: eg. intensity of pain, itching... (10 items). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | 6 months after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatology Quality of life at 12 months | Self-reported dermatology quality of life using the standardized Dermatology Life Quality Index (DLQI) ; This score assess the functional impact of fibrosis: eg. intensity of pain, itching... (10 items). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
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Inclusion Criteria:
Exclusion Criteria:
age <18 or ≥ 80 years old
evolutive cancer
Metastatic Disease
Patient undergoing specific treatment for breast cancer (except adjuvant endocrine therapy and / or adjuvant Herceptin) at the time of inclusion
bilateral Breast/chest wall Radiotherapy
breast prosthesis bearer
Body Mass Index > 40 or <18.5
chronic skin ulceration within the treated breast at the time of inclusion
contraindications to spa care :
evolutive chronic skin disease
hypersensitivity to pentoxifylline or any of the excipients
acute myocardial infarction
ongoing hemorrhage or major bleeding risk
use of oral anticoagulants
pregnant or likely to be in 6 months or breastfeeding
patients deprived of liberty or under supervision
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MERLIN Jean Louis | Contact | 0033383598307 | jl.merlin@nancy.unicancer.fr | |
| FERNANDES Laurinda | Contact | 0033383598487 | l.fernandes@nancy.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| VOGIN Guillaume, MD,PhD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon Hôpital Jean Minjoz | Besançon | 25000 | France |
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| Pentoxifylline | Drug | 400 mg bid during at least 6 months |
|
| Tocopherol acetate | Drug | 500 mg bid during at least 6 months |
|
| 12 months after the end of treatment |
| Overall quality of life | quality of life questionnaire (EORTC QLQ C30 score) | 6 months |
| Breast-oriented quality of life | EORTC QLQ-BR23 score | 6 months |
| late radiation toxicity | Evaluation of late toxicity performed independently and in blind by another radiation oncologist from the same center, using the CTCAE v4.0 scale modules: Skin and subcutaneous tissue disorders / Musculoskeletal skeletal / Reproductive organs and breast | 6 months |
| Skin thickness | The skin thickness will be assessed in blind by an independently radiologist using a standardized Ultrasound scan procedure (Yoshida EJ, et al; Int J Radiat Oncol Biol Phys. 2012) Skin thickness is measured as the distance between the entry ultrasound echo signal to the border between the dermis and hypodermis . Measurements are acquired from ten locations: five on the treated (irradiated) breast (12:00, 3:00, 6:00, 9:00, and tumor bed), and five corresponding locations on the untreated (contralateral) breast - serving as controls to account for patient baseline variation | 6 months |
| Cosmetic appearance | The cosmetic appearance will be evaluated by the investigator with the Harvard-breast-cosmesis-scale (HBCS). HBCS classifies the overall aesthetic results in four categories from excellent, good, fair to poor; comparing the treated breast to the control breast | 6 months |
| ONCODOC | Béziers | 34500 | France |
|
| Centre d'Oncologie et de Radiothérapie du Parc | Chalon-sur-Saône | 71100 | France |
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| Clinique du Parc de Charleville-Mézières | Charleville-Mézières | 08000 | France |
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| CLCC Jean Perrin | Clermont-Ferrand | 63000 | France |
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| Hôpitaux Civils de Colmar | Colmar | 68000 | France |
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| Centre Georges-François Leclerc | Dijon | 21079 | France |
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| Institut Daniel Hollard | Grenoble | 38000 | France |
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| CHU de Grenoble, Hôpital A.Michallon | La Tronche | 38700 | France |
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| CHR Metz-Thionville Hôpital de Mercy | Metz | France |
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| CH de Belfort-Montbéliard Site du Mittan | Montbéliard | 25200 | France |
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| CH de Mulhouse | Mulhouse | 68100 | France |
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| Centre d'Oncologie de Gentilly | Nancy | 54100 | France |
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| CHU de Poitiers | Poitiers | 86000 | France |
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| Institut Jean Godinot de Reims | Reims | 51100 | France |
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| CLCC Saint Etienne | Saint-Priest-en-Jarez | 42270 | France |
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| Centre Paul Strauss | Strasbourg | 67000 | France |
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| Clinique de l'Orangerie | Strasbourg | 67000 | France |
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| Institut Universitaire du Cancer | Toulouse | 31000 | France |
|
| CH de Troyes | Troyes | 10000 | France |
|
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| D024502 | alpha-Tocopherol |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D024505 | Tocopherols |
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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