Clinical Benefit of Spa Care on Severe Radiation-induced Fibrosis After Postoperative Radiotherapy for Breast Cancer

Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission

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.

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