A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 870
- 试验地点
- 1
- 主要终点
- Changes in wrist function
研究概览
简要总结
Postmenopausal women with hormone receptor-positive breast cancer are now prescribed aromatase inhibitors with 5 years or longer durations of therapy as recommended by clinical guidelines, which contributes to reducing breast cancer recurrence. However, aromatase inhibitors treatment is associated with a high incidence of musculoskeletal symptoms (MSS), often described as symmetrical pain, soreness in the joints, musculoskeletal pain, and joint stiffness, which even leads to bone loss, osteoporosis, and fractures. MSS reduces patients' quality of life and compliance with aromatase inhibitors therapy in up to one-half of women undergoing adjuvant aromatase inhibitors therapy, potentially compromising breast cancer outcomes. Therefore, this study aimed to monitor the musculoskeletal health of breast cancer patients during endocrine therapy to provide references for clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postoperative early breast cancer；
- •Hormone receptor-positive breast cancer diagnosed by pathology；
- •Aromatase inhibitor therapy (e.g., anastrozole, letrozole, exemestane) was initiated within 3 months;
- •Postmenopausal women, or premenopausal or perimenopausal women taking ovarian function inhibitors;
- •Informed consent and voluntary participation in the study.
排除标准
- •Breast cancer recurrence or distant metastasis;
- •With other malignant tumors;
- •With cognitive or psychiatric disorders.
结局指标
主要结局
Changes in wrist function
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Measured with Boston Carpal Tunnel Questionnaire (BCTQ).
Changes in knee or hip joint function
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Measured with Western Ontario and McMaster Osteoarthritis Index (WOMAC).
Changes in hand function
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Measured with score for assessment and quantification of chronic rheumatic affections of the hands (SACRAH).
次要结局
- Depression and Anxiety(Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.)
- Bone mineral density(Baseline, 12 months, and 24 months.)
- Grip strength(Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.)
- Medication adherence(Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.)
研究者
Feng Jing
Principal Investigator
Fudan University