Tonation Breathing Technique, a Non-Pharmacogenic Method to Ease Aromatase Inhibitor-Induced Musculoskeletal Symptoms - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in aromatase inhibitor induced musculoskeletal pain symptoms
研究概览
简要总结
This clinical trial evaluates how well tonation breathing techniques (use of a breathing and tonation [creating sounds]) works to ease pain joint and/or muscle pain in patients with stage I-III breast cancer and currently take an aromatase inhibitor. Tonation breathing techniques may help relieve pain in patients with stage I-III breast cancer who are receiving aromatase inhibitor.
详细描述
PRIMARY OBJECTIVE:
I. To study impact of active participation of patients in producing tones in combination with breathing technique, i.e., tonation breathing techniques (TBT) to reduce aromatase inhibitor induced musculoskeletal symptoms.
OUTLINE:
Patients participate in tonation breathing techniques twice daily (or more if pain occurs) for 2 weeks. Patients also complete questionnaire at baseline and at 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Females with stage I-III breast cancer taking adjuvant aromatase inhibitor (AI) (either standard dose of anastrozole 1 mg daily or letrozole 2.5 mg daily or exemestane 25 mg daily) for greater than 30 days experiencing AI induced musculoskeletal pain scores of 5 or higher on a Likert scale will be enrolled
- •Subjects should have completed any planned surgery for breast cancer, chemotherapy and radiation therapy at least 30 days prior to enrollment
- •Patients should have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
- •Patients should be at least 18 years old with no maximum age limit
排除标准
- •Patients should not have significant underlying pulmonary disease
结局指标
主要结局
Change in aromatase inhibitor induced musculoskeletal pain symptoms
时间窗: Baseline to 2 weeks
Patients will be asked to complete a validated brief pain inventory- SF ( BPI-SF) at baseline and after 2 weeks which would be end of study. The BPI- SF measures pain intensity at its worse in the last week, at its least in the last week in addition to average pain and location of pain. It also measures relief of pain from pain treatments or medications and percentage of relief.
次要结局
未报告次要终点