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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Cancérologie de Lorraine
• Collaborator: Association Francaise pour la Recherche Thermale
• Treatments: alpha-Tocopherol; Pentoxifylline; Tocopherols; Tocotrienols; Vitamin E

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