Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 142
- 试验地点
- 21
- 主要终点
- Dermatology Quality of life at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
combination tocopherol/pentoxifylline + spa care
pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days)
干预措施: skin-oriented spa care (Other)
combination tocopherol/pentoxifylline + spa care
pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days)
干预措施: Pentoxifylline (Drug)
combination tocopherol/pentoxifylline + spa care
pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days)
干预措施: Tocopherol acetate (Drug)
combination tocopherol/pentoxifylline
pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months
干预措施: Pentoxifylline (Drug)
combination tocopherol/pentoxifylline
pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months
干预措施: Tocopherol acetate (Drug)
结局指标
主要结局
Dermatology Quality of life at 6 months
时间窗: 6 months after the end of treatment
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.
次要结局
- Breast-oriented quality of life(6 months)
- late radiation toxicity(6 months)
- Skin thickness(6 months)
- Dermatology Quality of life at 12 months(12 months after the end of treatment)
- Overall quality of life(6 months)
- Cosmetic appearance(6 months)