Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group
研究概览
简要总结
Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90 percent of women treated.
Risk of flushing could be reduced by hygienic rules, but no treatment proved its efficacy to prevent radiodermatitis.
Homeopathy is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.
详细描述
Breast cancer is the second most frequent cancer worldwide, and the most frequent in France. Principal therapy consists in radiotherapy, that is locoregional, using radiations to kill cancerous cells.
Radiotherapy has sides effects as radiodermatitis, concerning about 90 percent of women treated. Radiodermatitis could be described with three factors : redness, heat, and edema.
Risk of flushing could be reduced by hygienic rules concerning hydratation, clothes, and toilet.
Nowadays, no treatment proved homeopathic efficacy to prevent radiodermatitis. This treatment is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither patients receiving pills nor doctors evaluating radiodermatitis know the nature of treatment (placebo or homeopathy)
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
- •Major patient;
- •Indication of curative intent radiotherapy for breast cancer treated with conservative treatment. Accepted radiotherapy scheme: 50 Gy (main) + 16 Gy on the tumor bed (additional dose);
- •Patient affiliated or entitled to a social security scheme;
- •Patient who signed an informed consent form.
排除标准
- •Pregnant or lactating woman;
- •Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent
- •Patient followed by a liberal homeopath;
- •Patient with bilateral breast cancer;
- •Patient with in situ breast cancer;
- •Patient with known cognitive impairment;
- •Patient with known allergy and / or intolerance and / or malabsorption to fructose, glucose, galactose;
- •Patient with a known deficiency in sucrase / isomaltase / lactase.
研究组 & 干预措施
Radium bromatum placebo group
Placebo group will receive placebo pills of Radium bromatum during radiotherapy
干预措施: Placebo pills of Radium bromatum (Drug)
Radium bromatum group
Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy
干预措施: Radium bromatum pills (Drug)
Radium bromatum/Apis mellifica/Belladonna placebo group
Placebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis
干预措施: Radium bromatum/Apis mellifica/Belladonna placebo pills (Drug)
Radium bromatum/Apis mellifica/Belladonna group
Radium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis
干预措施: Radium bromatum/Apis mellifica/Belladonna pills (Drug)
结局指标
主要结局
Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group
时间窗: Week 6
Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group will be measure with the RTOG (Radiation Therapy Oncology Group) scale. A diminution of 10% between Radium bromatum group and placebo group will be considered as significant
次要结局
- Radiodermatitis frequency(Week 6)
- Radiodermatitis delays(Week 6)
- Pain measure(Week 6)
- Satisfaction measure(Week 6)
- Number of concomitant treatments(Week 6)
- Level of Quality of life(Week 6)
- Radiodermatitis duration(Week 6)