Clinical trial NCT02898376: Clinical Benefit of Spa Care on Severe Radiation-induced Fibrosis After Postoperative Radiotherapy for Breast Cancer
Official title: Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Carcinoma
Fibrosis
Keywords: spa care
randomised controlled trial
pentoxifylline/tocopherol combination
late sequelae
radiotherapy
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
Collaborators: name: Association Francaise pour la Recherche Thermale
First posted: 2016-09-13
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* women
* age ≥ 18 and \<80 years old
* invasive or in situ breast carcinoma
* non-metastatic disease.
* postoperative radiotherapy completed since at least 6 months
* unilateral breast radiotherapy
* grade \> 2 dermal and/or soft tissue toxicity (CTCAE v4.0)
* no inflammatory ou infectious flare on the breast at the time of inclusion
* ability to provide an informed written consent form
* affiliation to a social security system

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 :

  * inflammatory disease in flare at the time of inclusion
  * active infections
  * heart failure (NYHA class\> 1)
  * chronic respiratory failure
  * labile blood pressure
  * bullous dermatitis
* 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

Primary outcomes:
measure: Dermatology Quality of life at 6 months
timeFrame: 6 months after the end of treatment
Secondary outcomes:
measure: Dermatology Quality of life at 12 months
timeFrame: 12 months after the end of treatment
measure: Overall quality of life
timeFrame: 6 months
measure: Breast-oriented quality of life
timeFrame: 6 months
measure: late radiation toxicity
timeFrame: 6 months
measure: Skin thickness
timeFrame: 6 months
measure: Cosmetic appearance
timeFrame: 6 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon Hôpital Jean Minjoz
city: Béziers
country: France
facility: ONCODOC
city: Chalon-sur-Saône
country: France
facility: Centre d'Oncologie et de Radiothérapie du Parc
city: Charleville-Mézières
country: France
facility: Clinique du Parc de Charleville-Mézières
city: Clermont Ferrand
country: France
facility: CLCC Jean Perrin
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Grenoble
country: France
facility: Institut Daniel Hollard
city: La Tronche
country: France
facility: CHU de Grenoble, Hôpital A.Michallon
city: Metz
country: France
facility: CHR Metz-Thionville Hôpital de Mercy
city: Montbéliard
country: France
facility: CH de Belfort-Montbéliard Site du Mittan
city: Mulhouse
country: France
facility: CH de Mulhouse
city: Nancy
country: France
facility: Centre d'Oncologie de Gentilly
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: Institut Jean Godinot de Reims
city: Saint-Priest en Jarez
country: France
facility: CLCC Saint Etienne
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Strasbourg
country: France
facility: Clinique de l'Orangerie
city: Toulouse
country: France
facility: Institut Universitaire du Cancer
city: Troyes
country: France
facility: CH de Troyes
city: Vandoeuvre-les-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: VOGIN Guillaume, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: