Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer in Remission
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 13
- 主要终点
- Evaluation of the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis after a dermatologically oriented spa treatment.
研究概览
简要总结
FIBROTHERME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial.
The aim of this study is to evaluate the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis 6 months after a dermatologically oriented spa therapy in patients with severe late reactions affecting the skin and/or soft tissues at least 6 months after radiotherapy for breast cancer or UADT (Upper Aerodigestive Tract) cancer.
详细描述
Radiation-induced fibrosis is an equivalent of an "orphan disease", in which oncologists have only recently shown interest, despite its prevalence. No study on the medical service provided by crenotherapy has been published in late radiation-induced fibrosis, which shares a common pathophysiology and medico-psycho-social sequelae with the sequelae of burns.
Chronic progressive dermatoses are part of the 12 main therapeutic orientations of medical thermalism. In particular, burn scars are a very current indication. Crenotherapy allows the attenuation, or even the disappearance of: pruritus and dysesthesia, local inflammation, hypertrophy and sclerosis and favours the recovery of chronic superficial erosions. Fibrous scars, even old ones, respond favourably to thermal treatments. The thermal treatment combines baths which have a sedative, muscle-relaxing effect and which favour joint mobilisation, sprays which have a decongestant effect and above all thread-like showers which are carried out by jets of thermal water under high pressure for several minutes.
The primary endpoint is the self-assessment by the patient of the dermatological quality of life by the DLQI score at 6 months after the end of the treatment compared between the intervention group (immediate treatment) and the control group (delayed treatment after 6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Randomisation will be carried out by the coordinating centre by telephone. This methodology will maintain the investigator's blindness, the coordinating centre will ask the patient not to talk to the investigator about her treatment during follow-up visits.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •In situ or invasive breast cancer or cancer of the upper aerodigestive tract
- •DLQI ≥ 6 (at least moderate effect on patient's life)
- •General status WHO 0-1
- •Radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay)
- •Unilateral breast radiotherapy for breast cancer patients
- •Skin or soft tissue toxicity (- modules: Skin atrophy, fibrosis of deep connective tissues, fibrosis of superficial soft tissues) CTCAE v4.0 grade ≥ 2
- •No inflammatory or infectious flare at inclusion
- •Female of childbearing potential: negative urine pregnancy test at inclusion
- •Patient informed and signed consent
- •Affiliation to a social security systeme or equivalent
排除标准
- •Progressive phase of cancer
- •Metastatic disease
- •Patient undergoing specific treatment for breast cancer (except adjuvant hormone therapy and/or adjuvant herceptin)
- •Bilateral breast/parietal radiotherapy
- •Breast prosthesis wearer for breast cancer patients
- •Patient with a tracheostomy for patients with head and neck cancer
- •Obvious skin ulceration in the site of interest
- •Contraindication to spa treatment (acute inflammatory disease, active infections, heart failure with NYHA stage > 1, chronic respiratory failure, labile hypertension, bullous disease)
- •Chronic progressive dermatological disease
- •Women who are pregnant or likely to become pregnant within 6 months or who are breastfeeding
- •Persons deprived of liberty or under guardianship
研究组 & 干预措施
Immediate spa treatment
The spa treatment must be carried out within a maximum of 6 weeks after the inclusion visit.
干预措施: Thermal cure with a primary dermatological indication (Other)
Late spa treatment
The spa treatment must be carried out after the 6-month visit.
干预措施: Thermal cure with a primary dermatological indication (Other)
结局指标
主要结局
Evaluation of the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis after a dermatologically oriented spa treatment.
时间窗: 6 months
Self-assessment by the patient of the dermatological quality of life by the DLQI (Dermatology Life Quality Index) score at 6 months after the end of the treatment compared between the intervention group (immediate treatment) and the control group (delayed treatment after 6 months). The DLQI score is between 0 and 30 where a high score indicates a significant impairment of quality of life.
次要结局
- Sequelae self assessment(6 months)
- Lesions radiological assessment(6 months)
- Thickness radiological assessment(6 months)
- Cancer quality of life(6 months)
- Senological or Upper Aerodigestive Tract (UADT) Cancer quality of life(6 months)
- Subgroup analysis of the primary outcome(6 months)
- Consumption of treatment(6 months)
- Consumption of medical consultation(6 months)
- Generic quality of life(6 months)
- Adverse events(6 months)
- Long-term cure quality of life benefice(12 months)
- Volumetric aspect radiological assessment(6 months)
- Treatment effect size(12 months)