NCT03096041已完成不适用
Phase 3 Study Randomized Against Placebo, Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors in Adjuvant Treatment of Breast Cancer (TRIPLE-A)
Centre Francois Baclesse8 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2017年7月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 8
- 主要终点
- Decrease in the overall pain score
研究概览
简要总结
Auriculotherapy is a complementary medicine, with few side effects, without contraindication, inexpensive and not very restrictive.Its efficacy has been found in several tests especially for the treatment of intraoperative pain. It remains more controversial in other indications. Evaluation of the value of auriculotherapy is often difficult because of the methodological limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed to improve the articular pains of patients treated by AA. This Phase III study aims at validate this approach.
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
- Single (Participant)
盲法说明
Single blind
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
- •Patient over 18 years of age
- •Patients with anti-aromatases in adjuvant treatment of breast cancer
- •Menopausal women
- •Treatment with aromatase inhibitors (anti-aromatase, AA) initiated for more than 3 months. In the case of a change in anti-aromatase, the last treatment must be started for more than 3 months.
- •Musculoskeletal pain appearing or increased under AA:
- •Overall pain score of QCD ≥3 (on a scale of 0 to 10)
- •Pain on at least 2 sites
- •Pain for at least 3 months
- •History of radiotherapy and / or adjuvant chemotherapy authorized
- •Patients may have received tamoxifen
- •Patient affiliated to a social security system
- •Patient mastering the French language and able to complete the evaluation questionnaires
- •Free and Informed Consent
排除标准
- •Patients who have already undergone treatment in auriculotherapy for the same indication
- •Patient benefiting at the same time from a PNCAVT (acupuncture or homeopathy) for musculoskeletal pain
- •Wearing hearing aids hindering the placement of semi-permanent needles (ASP)
- •Wearing of a valve prosthesis
- •Patient under guardianship or unable to give informed consent
- •Patient unable to undergo medical follow-up for geographical, social or psychopathological reasons
结局指标
主要结局
Decrease in the overall pain score
时间窗: 3 months after auriculotherapy initiation
The proportion of patients with a 2-point or greater decrease in the overall pain
次要结局
未报告次要终点
研究者
研究点 (8)
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