Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 26
- 主要终点
- Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale (for upper limb lymphoedema).
研究概览
简要总结
THERMOEDEME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial.
The aim of this study is to evaluate effects of spa therapy in phlebology with a therapeutic education program in daily life of patients suffering lymphoedema.
详细描述
Lymphoedema is a chronic disease related to an insufficiency of the lymphatic system, which most often affects the limbs. Secondary forms are the most common, particularly those following surgical and radiotherapy treatments for cancer, the most classic being the post-therapeutic large arm of breast cancer.
The lymphoedema is a traditional phlebology indication in spa therapy. The spa therapy linked with therapeutic education could constitute a favorable environment for the treatment of lymphoedema.
The primary endpoint is the comparison of the rate of patients improved from baseline to 6 months on LMS27 (upper limb lymphoedema) or LYMQOL-LEG (lower limb lymphoedema) (Improvement is defined as 7 points between baseline and 6-month follow-up).
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
The investigator doesn't know the group of randomization of the patient. The spa therapy organisation is managed by the coordination center.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old and older
- •available for a spa treatment (phlebology indication) during 18 days and a follow up period of 15 months
- •with permanent lymphoedema of the upper or lower limb (2 ou 3 stade of International Society for Lymphology scale)
- •voluntary to participate to the study, informed consent form signed after appropriate information
- •affiliation to the social security system or equivalent
排除标准
- •cancer undergoing chemotherapy and radiotherapy treatment in primary phase
- •the baseline score of LMS27 or LYMQOL-LEG > 79
- •pain of upper limb linked with a radical plexitis
- •contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)
- •Erysipelas case history in the last 6 months or pachyderma and lymphangiectasia
- •no previous spa treatment for upper limb lymphoedema during the spa year
- •risk of intensive treatment in the next 6 months
- •subject participating to an other clinical study interventional
- •pregnancy, parturient or breast feeding
研究组 & 干预措施
Immediate spa treatment
Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts
干预措施: Immediate spa treatment (Other)
Late spa treatment
Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization
干预措施: Late spa treatment (Other)
结局指标
主要结局
Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale (for upper limb lymphoedema).
时间窗: 6 months
Rate of patients with an improvement of 7 points minimum of the LMS27 scale (specific quality of life scale in upper limb lymphoedema) at 6 months. The LMS27 scale is composed of 27 questions with 5 answers possible : never, rarely, sometimes, often, always. The answer's score is respectively 1 (worse outcome) to 5 (better outcome). The higher the score is, the better the lymphoedema quality of life is.
Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LYMQOL-LEG scale (for lower limb lymphoedema).
时间窗: 6 months
Rate of patients with an improvement of 7 points minimum of the LYMQOL-LEG scale (specific quality of life scale in lower limb lymphoedema) at 6 months. The LYMQOL-LEG scale is composed of 26 questions with 4 answers possible: not at all, a little, quite a bit, a lot. In order to to standardize with the LMS27 scale (for upper limb lymphoedema), the quotations are reversed: the answer's score is respectively 1 (worse outcome) to 4 (better outcome). The higher the score is, the better the lymphoedema quality of life is.
次要结局
- Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LMS27 scale (for upper lymphoedema).(6 and 12 months)
- Upper or lower limb evaluation(6 and 12 months)
- Consumption of care between the 2 groups (immediate treatment/delayed treatment)(6 and 12 months)
- Compliance of spa therapy(After spa therapy)
- Long term evaluation(12 months)
- Evolution of lymphoedema quality of life assessed by the LYMQOL-LEG scale (for lower limb lymphoedema) before / after spa therapy.(6 and 12 months)
- Sub group analysis(6 months)
- Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LYMQOL-LEG scale (for lower limb lymphoedema)(6 and 12 months)
- Improvement of quality of life assessed by the generic quality of life: Euroquol EQ5D-3L(6 and 12 months)
- Adverse events(12 months)
- Functional evaluation(12 months)
- Effect size(6 and 12 months)
- Evolution of lymphoedema quality of life assessed by the LMS27 scale (for upper limb lymphoedema) before / after spa therapy.(6 and 12 months)
- Achievement educational aims(3 months, 9 months.)